Diabetes clinical trials at University of California Health

112 in progress, 52 open to eligible people

Showing trials for

  • if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

    open to eligible people ages 12-28

    The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous beta cell function and influence glycemic parameters in adolescent and adults recently diagnosed with T1D carrying the HLA DR3-DQ2 haplotype.

    at UCSD

  • Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events

    open to eligible people ages 55 years and up

    TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.

    at UCLA

  • VX-880 in Participants With Type 1 Diabetes

    open to eligible people ages 18-65

    This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

    at UCSF

  • REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

    open to eligible people ages 30-80

    The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.

    at UC Davis

  • Acetazolamide in Persons with Type 1 Diabetes

    open to eligible people ages 18 years and up

    This is a dose finding trial where participants will receive escalating doses of acetazolamide, each for a 2-week dosing period followed by a 2-week washout period. The three doses examined will be open-label 62.5mg twice daily, 125mg twice daily, and 250mg twice daily of acetazolamide. A baseline Iohexol GFR (glomerular filtration rate) measurement will be performed prior to the first administration of each acetazolamide dose and then again following each dosing period. Including a screening visit and a follow-up visit, there will be a total of 8 study visits over approximately 16 weeks.

    at UCSD

  • Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem

    open to eligible people ages 18 years and up

    This study examines the impact of a multi-level intervention aiming to improve telehealth access for low-income patients managing chronic health conditions, such as hypertension and diabetes. The multi-level intervention includes clinic-level practice facilitation and patient-level digital health coaching.

    at UCSF

  • Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis

    open to eligible people ages 18-85

    This is a phase IIa randomized trial designed to evaluate bacteriophage therapy in patients with diabetic foot osteomyelitis.

    at UCLA

  • CGM in Kidney Transplant Recipients

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    open to eligible people ages 18 years and up

    The investigators want to study the impact CGM (continuous glucose monitoring) has on patients glycemic control as determined by time in range (TIR 70-180 mg/dL) in the Diabetic Kidney Transplant population.

    at UC Davis

  • Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

    open to eligible people ages 18-70

    This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.

    at UCSD

  • Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

    open to eligible females ages 18 years and up

    A pilot randomized control trial (RCT) to examine the efficacy of a culturally tailored mindfulness intervention upon fasting cardiometabolic factors (including markers of glycemic control) and inflammatory gene expression in n=60 (n=30 intervention, n=30 wait-list control) low-income Spanish-speaking Latina pregnant women. The study will be conducted in partnership with MOMS, a nonprofit community organization that serves low-income pregnant and postpartum women.

    at UC Irvine

  • Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial

    open to eligible people ages 18-99

    This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.

    at UC Irvine

  • Continuous Glucose Monitoring System Feasibility in Youth With T2D

    open to eligible people ages 8-20

    The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.

    at UCSF

  • Dementia and Diabetes Prevention Program

    open to eligible people ages 60 years and up

    This is a multicenter, randomized 2-arm clinical trial of two lifestyle interventions varying in intensity and format, in 400 older African American and non-Hispanic whites at increased risk of cognitive decline and dementia in the East San Francisco Bay Area. The trial will include two lifestyle interventions that differ in intensity and format: 1. Aerobic Exercise (AEx) Intervention that involves aerobic activities with in-class walking workouts and tutorials and carried out at the East Oakland Sports Center (EOSC) and Tice Creek Fitness Center (TICE). 2. Dietary counseling to support adherence to the Mediterranean-Diet Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet to encourage increased consumption of berries, green leafy and other vegetables, whole grains, nuts, fish, poultry, beans and olive oil, and to reduce consumption of fried/fast foods, red meat, whole fat cheese, sweets, butter and trans-fat margarines.

    at UC Davis

  • DETERMINE: Detemir vs NPH

    open to eligible people ages 18 years and up

    The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

    at UCLA

  • Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes

    open to eligible people ages 18 years and up

    There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.

    at UCSD

  • Device Use Reimagined Through Education And Mentorship

    open to eligible people ages 13-17

    Diabetes technology, such as insulin pumps and continuous glucose monitoring devices, can help improve glucose control for people with type 1 diabetes (T1D), which keeps them at lower risk for diabetes complications, but many Latinx adolescents, who make up the largest marginalized ethnic group of youth with T1D in California, use these devices less often and have less optimal glucose control compared to White youth. In phase 1 of this project, we worked directly with Latinx youth, their families, and diabetes care team members in California to develop DREAM, Device use Reimagined through Education And Mentorship, a virtual peer group (VPG) intervention that will encourage and support the use of diabetes devices in Latinx adolescents with T1D. The goals for phase 2 (intervention) of this project are to evaluate the feasibility and acceptability of the stakeholder-informed VPG intervention, and evaluate clinical and person-centered outcomes.

    at UC Davis UCSF

  • Dietary Intervention to Improve Kidney Transplant Outcomes

    open to eligible people ages 18 years and up

    Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant

    at UC Davis

  • Dosimetry of Tc-99m-Tilmanocept

    open to eligible people ages 18 years and up

    This proposal will use kidney SPECT/CT of Tc-99m-tilmanocept to evaluate the mesangial changes seen in diabetics across the spectrum of kidney disease as well as persons with hypertensive kidney disease, the next most common cause of kidney disease in patients with diabetes. We aim to demonstrate that these different disease types and stages can be differentiated with Tc-99m-tilmanocept SPECT/CT and can thus be used for future trials evaluating early diagnosis and treatment of diabetic nephropathy.

    at UCSD

  • Metformin, a Drug Used to Treat Diabetes, vs Placebo

    open to eligible people ages 18 years and up

    Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.

    at UCLA

  • Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

    open to eligible people ages 18 years and up

    The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

    at UCLA

  • Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

    open to eligible people ages 40-80

    A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.

    at UCLA

  • EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA

    open to eligible people ages 18 years and up

    The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.

    at UCSD

  • EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy

    open to eligible people ages 18 years and up

    This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol.

    at UCSD

  • Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

    open to eligible people ages 18-70

    To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

    at UCSD

  • Bolus for Meals in a Closed-loop System

    open to eligible people ages 13-19

    This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.

    at UCSF

  • Fenofibrate for Prevention of DR Worsening

    open to eligible people ages 18-80

    This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.

    at UC Davis UCSF

  • FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

    open to eligible people ages 12-35

    This is a randomized, parallel group, double-blind Phase 2 study with a 52-week blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks Double-blind treatment period (104 weeks): - Main treatment period: 52 weeks - Blinded extension: 52 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

    at UCSF

  • Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes

    open to eligible people ages 18-68

    This clinical study will evaluate the safety and effectiveness of Gastrin treatment with islet transplantation to help patients with difficult to control type 1 diabetes make insulin again and improve blood sugar control. This study involves two investigational (experimental) products not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease: 1. Human allogenic islet cells (islet cells from a deceased, unrelated human donor) 2. Gastrin-17 (Gastrin) - a hormone secreted by the gut

    at UCLA

  • Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

    open to eligible people ages 18 years and up

    This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.

    at UCLA UCSD

  • Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

    open to eligible people ages 12-35

    A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

    at UCSF

  • More Fresh Fruit and Vegetable Prescription Program for Families with Type 2 Diabetes Mellitus

    open to eligible people ages up to 18 years

    Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).

    at UCSD

  • Precision Dosing of Metformin in Youth With T2D

    open to eligible people ages 10-21

    The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

    at UCSF

  • Cannabis Derivatives in Neuropathic Pain

    open to eligible people ages 21 years and up

    Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital.

    at UCSD

  • Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC)

    open to eligible people ages 18 years and up

    The Next Day Clinic (NDC) is a quality improvement initiative that will be launched and operated by UCLA Health starting July 22, 2024. Its goals are to improve patient care and safety and to maximize cost effectiveness. The way it does this is by identifying patients in the ED who would normally be admitted for low-acuity conditions, and diverting them to a high-acuity clinic the following day called the NDC. This will help decompress the ED and the hospital, and allow for overall higher quality care. The Health System has partnered with UCLA's Healthcare Value Analytics and Solutions [UVAS] group which specializes in these types of program evaluations. The analysis conducted by the study team will be used to directly inform NDC operations, scaling, and future plans.

    at UCLA

  • Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes

    open to eligible people ages 5-18

    This study will test the hypothesis that supplemental synchronous video visits and supplemental asynchronous remote monitoring can each significantly improve glycemic control for pediatric patients with uncontrolled type 1 diabetes over a 6 month period, and will compare health outcomes and patient-centered outcomes between these two intervention arms and a control arm receiving usual care.

    at UC Davis

  • Rituximab-pvvr and Abatacept Vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

    open to eligible people ages 8-45

    The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.

    at UCSF

  • Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

    open to eligible people ages 22-70

    This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

    at UCLA

  • MiniMed™ 780G System with DS5 CGM in Children

    open to eligible people ages 2-6

    The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.

    at UCSF

  • Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM

    open to eligible people ages 40-79

    Conduct a community intervention study that will 1) validate a screening approach to identify patients at risk for advanced NAFLD in the obese or T2DM population, and 2) test whether semaglutide treatment is effective for the management of significant fibrosis due to NAFLD in high-risk patients.

    at UCSD

  • Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

    open to eligible people ages 21-85

    Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.

    at UC Davis

  • SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

    open to eligible people ages 18 years and up

    The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

    at UCSF

  • Starting Technology in At Risk Type 1 Diabetes Study

    open to eligible people ages 18 years and up

    Diabetes technology has revolutionized T1D management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled T1D (A1c>8.5%). In order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly White, higher SES). Therefore, the investigators propose to perform a pilot RCT of hybrid closed-loop insulin pump therapy (HCL) in 40 diverse adult patients with poorly controlled T1D (HbA1c >8.5%) from the largest academic and safety net health systems in the Los Angeles region to determine the feasibility of a RCT in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled T1D.

    at UCLA

  • Time-Restricted Eating for Type II Diabetes: TRE-T2D

    open to eligible people ages 18-75

    This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).

    at UCSD

  • Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

    open to eligible people ages 22-90

    The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

    at UCLA

  • Type 2 Diabetes and Blood Brain Barrier Improvement

    open to eligible people ages 40-65

    The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours.

    at UCLA

  • Commercial or Open Source Closed Loop Impact on Pregnancy Study

    open to eligible females ages 18 years and up

    The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are: - What are the maternal and neonatal outcomes with AID system use in pregnancy? - What are the glycemic outcomes with AID system use in pregnancy? - What are the behavioral and emotional outcomes with AID system use in pregnancy? Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems. Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.

    at UCSF

  • Designing Team Clinic for Youth with Type 2 Diabetes

    open to eligible people ages 12-18

    The goal of this clinical trial is to learn about if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question[s] it aims to answer are: - Design four group activities centered around nutrition therapy, peer interactions, exercise and stress management. - Design the clinical workflow for implementation phase. Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

    at UCSF

  • DFC 004 Biomarkers for Active Diabetic Foot Ulcers

    open to eligible people ages 18 years and up

    This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions

    at UCSF

  • Inflammation, Diabetes, Ethnicity and Obesity Cohort

    open to eligible people ages 18-75

    Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time. In this proposed study, investigators will recruit participants from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area.

    at UCSF

  • PS230005 Control-IQ 1.5 Post-Approval Study

    open to eligible people ages 2-5

    This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to <6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.

    at UCSD

  • TrialNet Pathway to Prevention of T1D

    open to eligible people ages 2-45

    Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.

    at UCLA UCSF

  • Type 1 Diabetes Extension Study

    open to eligible people ages 8-35

    This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: - follow participants to determine how long they continue to produce insulin, and - will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future.

    at UCSF

  • Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

    Sorry, in progress, not accepting new patients

    Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

    at UCLA

  • Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

    Sorry, in progress, not accepting new patients

    Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

    at UCLA

  • Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

    Sorry, in progress, not accepting new patients

    The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

    at UCLA

  • Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

    Sorry, not currently recruiting here

    The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

    at UCLA UCSF

  • Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

    Sorry, in progress, not accepting new patients

    Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.

    at UCSD

  • Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

    Sorry, in progress, not accepting new patients

    The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

    at UCLA UCSD

  • Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

    Sorry, in progress, not accepting new patients

    Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months. During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.

    at UCLA

  • Achieving Routine Intervention and Screening for Emotional Health

    Sorry, not yet accepting patients

    The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

    at UCSF

  • Afrezza® INHALE-1 Study in Pediatrics

    Sorry, in progress, not accepting new patients

    INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and <18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: - Up to 5-week screening/run-in period - 26 week randomized treatment period - 26-week treatment extension - 4-week follow-up period

    at UCSD UCSF

  • Automated Insulin for Management of Intrapartum Glycemia

    Sorry, not yet accepting patients

    The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are - What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? - Do patients report higher birth satisfaction with use of AID systems during labor/delivery? - Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery? Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.

    at UCSF

  • CGM for Management of Type 2 Diabetes in Pregnancy

    Sorry, not currently recruiting here

    The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis

    at UCSD

  • Changing Health Through Food Support for Diabetes

    Sorry, in progress, not accepting new patients

    This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic control and other cardiometabolic outcomes, investigate the paths through which CHEFS-DM may durably improve health, and assess the economic value of the intervention to society.

    at UCSF

  • Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

    “We hope to learn more about the safety and feasibility of using your own (autologous) stem cells extracted from your bone marrow.”

    Sorry, in progress, not accepting new patients

    This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.

    at UC Davis

  • Closed Loop and Education for Hypoglycemia Awareness Restoration

    Sorry, not yet accepting patients

    The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.

    at UCSD

  • Cryoneurolysis for Painful Diabetic Neuropathy of the Foot

    Sorry, not yet accepting patients

    The study is a single-center, randomized, participant- and observer-masked, human-subjects, post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 6 minutes for each nerve, involves little discomfort, has no systemic side effects, and cannot be misused or become addictive. Participants will be randomly allocated to one of two possible treatments groups: cryoneurolysis (experimental) or sham (control). The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure.

    at UCSD

  • Daily Blood Glucose Trends in Patients at Risk for Diabetes

    Sorry, not yet accepting patients

    The goal of this study is to learn about the relationship between blood sugar, diet, stress, and metabolic parameters including waist circumference, body mass index (BMI), cholesterol levels and blood pressure in patients at risk for diabetes. The main questions it aims to answer are 1) are there trends in blood sugar responses after meals for patients at risk of developing diabetes? And 2) are there correlations between stress and fluctuations in blood sugar? During the first visit, participant's waist circumference, body composition, cholesterol, and resting blood pressure will be measured, and a continuous glucose monitor sensor will be placed on the participant's non-dominant arm. This sensor will be worn for seven days, and the participant will be asked to complete a daily food log during that time. Each participant will be asked to return to clinic after one week to return the continuous glucose monitor and daily food log.

    at UCLA

  • DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

    Sorry, not currently recruiting here

    This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

    at UCSF

  • Dexcom G6 Continuous Glucose Monitoring in Hemodialysis

    Sorry, in progress, not accepting new patients

    This is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the University of California Irvine Medical Center (UCIMC) who will undergo simultaneous measurement of glucose levels using 1) continuous glucose monitor (CGM) measured by a Dexcom G6 device vs. 2) "gold-standard" blood glucose levels using capillary fingerstick or venous blood glucose measurements obtained on a point of care (POC) blood glucose meter. The study will assess Dexcom G6 accuracy by comparing glucose levels on the CGM device vs. blood glucose measurements in the study population.

    at UC Irvine

  • Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients

    Sorry, in progress, not accepting new patients

    The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.

    at UCSD UCSF

  • Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence

    Sorry, accepting new patients by invitation only

    This research study is being conducted to improve eye care by using artificial intelligence (AI) to make diabetic eye screenings faster and more accessible. AI technology mimics human decision-making, enabling computers and systems to analyze medication information. Specifically for this screening, AI examines digital images of the eye and based on that information, may identify if a participant has diabetic retinopathy. It can assist doctors in making decisions about a participant's diagnosis, treatment or care plans to improve patient care. This is a collaboration between San Ysidro Health (SYHealth), University of California, San Diego (UC San Diego), and Eyenuk. The Kaiser Permanente Augmented Intelligence in Medicine and Healthcare Initiative (AIM-HI) awarded SYHealth funds to demonstrate the value of AI technologies in diverse, real-world settings.

    at UCSD

  • GRA in Patients With Type 1

    Sorry, in progress, not accepting new patients

    This study will examine the effects a Glucagon Receptor Antagonist (GRA), has on Insulin Sensitivity, Cardiovascular risks (CVD), and Ketone body formation in participants with Type 1 diabetes. The participants will complete blood tests, tests to measure energy expenditure, CVD risks, and insulin resistance. These tests will be performed prior to start of treatment and again after 12-weeks of treatment with the GRA (called REMD-477).

    at UCSD

  • DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes

    Sorry, currently not accepting new patients, but might later

    The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.

    at UCLA

  • Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity Training in CKD

    “Adults ages 30-80 with Chronic Kidney Disease can participate in a new exercise study to help improve muscle function. See if you qualify!”

    Sorry, in progress, not accepting new patients

    Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of CKD with substantial adverse clinical consequences of disability, hospitalization, and death. Sarcopenia in this proposal is defined by impaired metabolism and physical function associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial energetics is a central mechanism of sarcopenia in CKD. The investigators propose a series of studies designed to shed light on the pathophysiology of sarcopenia in persons with CKD not treated with dialysis. Investigators will conduct a randomized-controlled intervention trial of combined resistance training and aerobic exercise vs. health education to assess changes in skeletal muscle mitochondrial function, metabolism and physical function. Investigators hypothesize that exercise improves mitochondrial function and physical function in persons with CKD. If successful, these experiments will identify novel pathophysiologic mechanisms for CKD-associated sarcopenia. The proposed study will provide useful insight into benefits associated with exercise among patients with CKD and investigate mechanisms associated with improved metabolism, muscle function and physical function in population.

    at UC Davis

  • Fully Closed Loop At Home (FCL@Home)

    Sorry, in progress, not accepting new patients

    Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The trial will aim to complete a total of 36 participants: 12 total participants within each age category and 18 participants within each HbA1c category; 12 participants at each site. The study may enroll up to 70 participants to account for dropouts across the study. The study will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel session, participants will undergo a 7 day/6-night remote monitored at-home use session. The study will also conduct a two-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy. Participants will be randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET use) or group B (control period after AIDANET use).

    at UCSF

  • Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab

    Sorry, not currently recruiting here

    This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled. After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline.

    at UCSD

  • Team Clinic for Type 2 Diabetes (TCT2)

    Sorry, not yet accepting patients

    The goal of this clinical trial is to learn if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question[s] it aims to answer are: - Is shared medical appointments an acceptable care delivery model for this population? - Does shared medical appointment improve psychosocial outcomes for this population? Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

    at UCSF

  • Islet Cell Transplant for Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and transplanting them into the liver of a patient with diabetes. Once transplanted, the islets produce insulin, which can improve blood sugar control and eliminate the need to inject insulin or use an insulin pump. Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted things like infections but can also attack transplanted cells and organs. Reducing the number of T-cells at the time of transplant may protect islets and improve long-term transplant success. In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some cases, allowing patients with type 1 diabetes to stop taking insulin. The purpose of this study is to determine if islet cell transplantation using ATG or alemtuzumab, along with additional medications to prevent the body from rejecting the transplanted cells, is a safe and effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.

    at UCLA

  • Islet Transplantation With Recipient T-Reg Cells or Deceased Donor Vertebral Bone Marrow Therapy

    Sorry, not yet accepting patients

    The goal of this clinical trial is to learn if patients who have brittle type 1 diabetes receiving an islet transplantation will have better control of their sugars if they also receive one of 2 types of immune cells along with the islet transplant. The participants will receive either their own immune cells, called regulatory T cells, or immune cells from the bone marrow of the islet donor.

    at UCSF

  • Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.

    at UCSF

  • Personalized Comprehensive Diabetes Support for Children With Newly Diagnosed Type 1 Diabetes

    Sorry, accepting new patients by invitation only

    The goal of this clinical trial is to learn if access to a diabetes coach improves quality of life (QOL) for families of children with newly diagnosed type 1 diabetes. The main questions it aims to answer are: 1. Determine if there are beneficial effects on diabetes-related QOL at the end of the 6-month intervention. 2. Determine if potential beneficial effects persist beyond completion of the support intervention, as measured by diabetes-related QOL at 12 months and 24 months following diagnosis Participants assigned to the intervention group will have access to a diabetes coach for 6 months following type 1 diabetes diagnosis. They will be compared to participants who are assigned to the control group and are receiving usual care.

    at UC Davis

  • RAY121 in Immunological Diseases (RAINBOW Trial)

    Sorry, not currently recruiting here

    This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

    at UC Irvine

  • Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease

    Sorry, accepting new patients by invitation only

    In this pilot clinical trial, the investigators will recruit and randomize 120 patients with diabetes mellitus and chronic kidney disease (CKD/DM) stages 3 to 5 to a patient-centered and flexible Plant-Focused Nutrition in Diabetes (PLAFOND) diet with >2/3 plant-based sources, which will be compared with a standard-of-care CKD diet, which is usually a low-potassium and low-salt diet, over a 6-month period. Through this study, the investigators will determine whether the plant-focused diet intervention is feasible for patient adherence, whether this diet is safe by avoiding malnutrition, frailty, and high potassium or glucose blood levels, and whether patient reported outcomes are favorably impacted.

    at UC Irvine UCLA

  • AT-001 in Patients With Diabetic Cardiomyopathy

    Sorry, in progress, not accepting new patients

    This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

    at UC Irvine UCLA UCSD

  • Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

    Sorry, not currently recruiting here

    This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.

    at UCLA

  • Siplizumab in T1DM

    Sorry, in progress, not accepting new patients

    This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. If indicated, participants will enter into long-term safety monitoring for up to an additional 48 weeks. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites. The primary objective is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM. The secondary objectives are to: 1. Assess the safety profile of siplizumab in recently diagnosed T1DM. 2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.

    at UCSF

  • STOP-T1D Low-Dose (ATG)

    Sorry, in progress, not accepting new patients

    A multi-center, placebo-controlled, double blind, 2:1 randomized control clinical trial testing low-dose ATG vs. placebo in subjects with a 2 year 50% risk of progression to stage 3 T1D.

    at UCSF

  • Strategies for Improving Linkage-to-Care After Eye Disease Screening

    Sorry, not yet accepting patients

    The goal of this randomized, parallel-group, controlled trial is to compare methods of enhancing linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening. Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from community health workers, or (3) no intervention. The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.

    at UCSF

  • Student Pharmacist Non-Pharmacological Intervention on Type 2 Diabetes Management in Older Asian Adult Populations

    Sorry, not yet accepting patients

    This study is being done to assess the impact of student pharmacist involvement on blood glucose control through non-pharmacological interventions in people of Asian and Asian descent over the age of 50 with type 2 diabetes. This study team is trying to advance the field of pharmacy and expand the roles of student pharmacists.

    at UCSF

  • Understand Risk Information to Support and Empower

    Sorry, accepting new patients by invitation only

    The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.

    at UC Davis

  • Suppression of Endogenous Glucose Production by Injectable HDV-Insulin Lispro: A Dose Response Study in Human Subjects With Type 1 Diabetes

    Sorry, not yet accepting patients

    Single-center, double-blind, random-sequence study assessing the HDV dose-response relationship to Endogenous Glucose Production (EGP), Free Fatty Acids (FFA) and Glucose Disposal Rate (GDR) during a euglycemic clamp procedure following overnight stabilization of blood glucose with intravenous insulin (and, if needed intravenous glucose). EGP and GDR will be determined using established radioisotope methodology. The concentration of Hepatic Directed Vesicles (HDV) in the insulin lispro (LIS) infused during the clamp procedure will be varied such that the percentage of HDV-bound LIS will range from 0%, 1%, 10%, and 100%. Each participant will thus undergo four clamp procedures at the four different HDV levels. LIS will be infused at a constant dose (6 mU/m2/min) for each of the four procedures.

    at UCSD

  • SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients with Type 1 and Type 2 Diabetes

    Sorry, not yet accepting patients

    The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.

    at UCSF

  • T-UP: Engaging Vulnerable Students in Diabetes Prevention

    Sorry, in progress, not accepting new patients

    The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.

    at UCLA

  • Teplizumab in Pediatric Stage 2 Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are <8 years of age.

    at UCSF

  • THC Effects on Glucose in Type 2 Diabetes

    Sorry, not yet accepting patients

    This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.

    at UCSD

  • Lifestyle Education About Nutrition for Diabetes (Legend) Study

    Sorry, in progress, not accepting new patients

    This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months. Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.

    at UCSF

  • Time Restricted Eating in Patients with Microalbuminuria

    Sorry, not yet accepting patients

    This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.

    at UCSD

  • Treatment of Type I Diabetes by Islet Transplantation Into the Gastric Submucosa Study Protocol

    Sorry, in progress, not accepting new patients

    The goal of this trial is to gain initial clinical experience regarding the safety and efficacy of treating type I diabetes in people who have received a kidney transplant by transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa). A total of 6 patients will be enrolled in the study and followed for a period of up to 3 years after the last islet transplant.

    at UCSF

  • UCLA Health Patient Health Maintenance Outreach Text Message

    Sorry, in progress, not accepting new patients

    This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text messages impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health's larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates.

    at UCLA

  • UCLA Health Patient Health Maintenance Text Reminder

    Sorry, in progress, not accepting new patients

    This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health's larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates.

    at UCLA

  • UCLA Health Patient Health Maintenance Text Reminder July 2023

    Sorry, in progress, not accepting new patients

    This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health's larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates.

    at UCLA

  • UCLA Health Patient Health Maintenance With Interactive Text Reminder

    Sorry, in progress, not accepting new patients

    This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach text message reminders impact patient engagement with primary care. This prospective randomized control trial is being implemented in conjunction with UCLA Health's larger quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order to improve primary care preventive measure completion rates.

    at UCLA

  • Wearable Sensors To Understand Low Blood Sugar in Type 1 Diabetes

    Sorry, not yet accepting patients

    This is a single-site study using wearable sensor technology (CGM and smartwatch) to better explain low blood sugars in patients living with type 1 diabetes. Up to 20 participants with T1D will wear a continuous glucose monitor (CGM) and a smartwatch to collect information about hypoglycemia (low blood sugar), heart rate variability (HRV), and sleep for 4 weeks. The main goal is to create a hypoglycemia risk score using wearable sensor metrics that can be easily applied to all patients with T1D to identify those at greater risk of hypoglycemia.

    at UCSD

  • AI Ready and Exploratory Atlas for Diabetes Insights

    Sorry, accepting new patients by invitation only

    The study will collect a cross-sectional dataset of 4000 people across the US from diverse racial/ethnic groups who are either 1) healthy, or 2) belong in one of the three stages of diabetes severity (pre-diabetes/diet controlled, oral medication and/or non-insulin-injectable medication controlled, or insulin dependent), forming a total of four groups of patients. Clinical data (social determinants of health surveys, continuous glucose monitoring data, biomarkers, genetic data, retinal imaging, cognitive testing, etc.) will be collected. The purpose of this project is data generation to allow future creation of artificial intelligence/machine learning (AI/ML) algorithms aimed at defining disease trajectories and underlying genetic links in different racial/ethnic cohorts. A smaller subgroup of participants will be invited to come for a follow-up visit in year 4 of the project (longitudinal arm of the study). Data will be placed in an open-source repository and samples will be sent to the study sample repository and used for future research.

    at UCSD

  • Cardiovascular Health Study (CHS)

    Sorry, in progress, not accepting new patients

    To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.

    at UC Davis

  • Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study

    Sorry, in progress, not accepting new patients

    This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.

    at UC Davis

  • HLA Demographics Study in Adults With Type 1 Diabetes

    Sorry, not yet accepting patients

    This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetes

    at UCSF

  • MIRACLE of LIFE Study

    Sorry, in progress, not accepting new patients

    The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

    at UCSD

  • Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

    Sorry, in progress, not accepting new patients

    The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.

    at UCLA

  • Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

    Sorry, in progress, not accepting new patients

    The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

    at UCSF

  • Diabetes Prevention Program Outcomes Study AD/ADRD Project

    Sorry, accepting new patients by invitation only

    The DPPOS AD/ADRD project will address the overarching question: What are the determinants and the nature of cognitive impairment among persons with pre-diabetes (PreD) and type 2 diabetes (T2D), who are a high-risk group for cognitive impairment and represent a large fraction of the United States (US) population? This U19 proposal addresses the National Alzheimer's Project Act goal to "prevent, halt, or reverse AD" in the high-risk group of persons with pre-diabetes and type 2 diabetes, who represent over half of the population aged 60 years and older in the US.

    at UCLA UCSD

Our lead scientists for Diabetes research studies include .

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