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Diabetes clinical trials at UC Health
65 in progress, 29 open to new patients

  • A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX

    open to eligible people ages 18-65

    This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.

    at UCLA

  • A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis

    open to eligible people ages 18 years and up

    This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

    at UCSD

  • A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

    open to eligible people ages 18-65

    The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.

    at UCSD

  • A Study of the Effect of Orange Juice or Sugar-Sweetened Beverages on Risk Factors for Type 2 Diabetes and Cardiovascular Disease

    “In this study, the study team will provide meals and either sugar-sweetened beverages or orange juice.”

    open to eligible people ages 18-50

    The objectives of this proposal are to address the gaps in knowledge regarding the metabolic effects of consuming orange juice, the most frequently consumed fruit juice in this country, compared to sugar-sweetened beverage.

    at UC Davis

  • A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria

    open to eligible people ages 25-75

    To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.

    at UCLA

  • Behavioral Family Therapy and Type One Diabetes

    open to eligible people ages 2-17

    Behavioral family therapy, specifically focused on insuring support for the primary caregiver of a child with type one diabetes mellitus and healthy family dynamics, may improve the child's glycemic control as measured by hemoglobin A1c level (HbA1c).

    at UC Davis

  • CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1

    open to eligible people ages 6-45

    The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM. Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.

    at UCSF

  • Dapagliflozin Effects on Hypoglycemia

    open to eligible people ages 18-70

    The purpose of this research study will be to test and evaluate if dapagliflozin has an effect on the amount of glucagon (a hormone produced by the pancreas and stomach that stimulates liver glucose production) produced by the body and if that change will improve recovery time from hypoglycemia (low blood sugar) in participants with Type 1 Diabetes.

    at UCSD

  • Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger

    open to eligible people ages 18 years and up

    Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S. Lifestyle modification is central to T2DM management, but long-term adherence to dietary recommendations is difficult. A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available. One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response. Such approaches seek to strengthen abilities to be non-judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively. The investigators hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence. The study will test a mindfulness-based intervention (MBI) for improving dietary adherence. Although the particular diet employed is not the focus of this study, the study will use a diet with about 10% of calories from carbohydrate as: (1) it induces a low level of ketone production, which will be used as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic parameters in T2DM, including glycemic control.

    at UCSF

  • Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes

    open to eligible people ages 18 years and up

    This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.

    at UCSD

  • Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)

    open to eligible females ages 18 years and up

    This study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and Fitbit activity trackers into routine clinical care

    at UCSD

  • Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

    open to eligible people ages 21-64

    This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.

    at UCSD

  • Habitual Diet and Avocado Trial

    open to eligible people ages 25 years and up

    The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).

    at UCLA

  • Inflammation, Diabetes, Ethnicity and Obesity Cohort

    open to eligible people ages 25-65

    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.

    at UCSF

  • Islet Cell Transplant for Type 1 Diabetes

    open to eligible people ages 18-68

    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) is an anti-rejection medication that works 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 is expected to protect islets and improve long-term transplant results. Transplant programs around the world have seen improved islet transplant results using T-cell depleting medications. Approximately 5-6 out of every 10 patients remain off insulin five years after transplant. These results are similar to those achieved with whole pancreas transplant without requiring major surgery, and therefore, may be an option for patients who are not eligible for a whole pancreas transplant. The purpose of this study is to determine if islet cell transplantation using ATG, 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

  • Measuring Sweat Glucose of Patients With Diabetes

    open to eligible people ages 18-60

    This pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.

    at UCSD

  • Metabolic Effects of Sugar and Aspartame

    “What are the effects of consuming sugar- and aspartame-sweetened beverages with standardized diets?”

    open to eligible people ages 18-40

    It is not known whether consumption of excessive amounts of sugar can increase risk factors for cardiovascular disease or diabetes in the absence of increased food (caloric) intake and weight gain, nor whether the negative effects of sugar consumption are made worse when accompanied by weight gain. This study will investigate the effects of excess sugar when consumed with an energy-balanced diet that prevents weight gain, and the effects of excess sugar when consumed with a diet that can cause weight gain. The results will determine whether excess sugar consumption and excess caloric intake that lead to weight gain have independent and additive effects on risk factors for cardiovascular disease or diabetes, and will have the potential to influence dietary guidelines and public health policy.

    at UC Davis

  • Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

    open to eligible people ages 18-65

    This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.2 ng/mL at Screening. The study will be conducted at multiple sites in the United States. Approximately 75 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.

    at UCSD

  • Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents

    open to eligible people ages 10-15

    The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.

    at UC Davis

  • Pathway to Prevention Study

    open to eligible people ages 1-45

    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 UCSF

  • Primary Care-Based Physical Activity for Diabetic Latinas

    open to eligible people ages 18-70

    The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes. The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months. The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.

    at UCSD

  • Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?

    open to eligible people ages 21 years and up

    In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the most advanced therapy. However, a significant number of these patients continue to have poor diabetes control. The most common reason is the noncompliance with multiple injections and the patient's reluctance to accept insulin-induced weight gain. More recently, the algorithm in diabetes management has significantly changed to accommodate the newer generation of medications. Addition of the diabetes medications, that can induce weight loss such as oral Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and once-weekly glucagon-like peptide (GLP)-1 receptor agonists (GLP1 RA) injection, to a basal insulin is now recommended before the patient is advanced to MDI. This approach works very well in most patients since weight loss gives the patients an extra motivation to take medication regularly. Similarly, the patient does not require to take an insulin injection before each meal throughout the day in this approach. Unfortunately, there are still a large number of patients with poor glycemic control who are still on MDI. Some of them were initiated on MDI before the availability of newer generations of medications. Some were started simply because the physician was not aware of or not the familiar with the new recommendations. Regardless of the reason, these patients are likely to remain on MDI despite chronic poor glycemic control since the physicians are understandably reluctant to step down the most advanced insulin therapy. In addition, there has been no data on the benefits and safety of the stepping-down approach from the most advanced insulin therapy to the more patient-friendly approach that is the combined use of oral SGLT2i and once-weekly GLP1 RA injection.

    at UCSF

  • Study to Understand Gaining Access to Blood Glucose Records

    open to eligible people ages 18 years and up

    This study is a two-arm randomized controlled trial in which participants will receive either the Livongo Health system or iHealth glucose meter for measuring their blood glucose. The study hypothesizes the use of the Livongo Health system results in a greater improvement in A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth Bluetooth-enabled glucose meter.

    at UCSF

  • T1DM Immunotherapy Using Polyclonal Tregs + IL-2

    open to eligible people ages 18-45

    The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.

    at UCSF

  • The Impact of Diabetes on REvascularization

    open to eligible people ages 35 years and up

    The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascularization has determined the effect of diabetes on mechanism of revascularization failure. Therefore, this trial represents a unique opportunity to investigate the mechanisms by which diabetes affects surgical and endovascular revascularization procedures with the long-term goal of improving outcomes in CLI.

    at UCSF UCLA

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

    open to eligible people ages 18-70

    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

  • Type 1 Diabetes Extension Study

    open to eligible people ages 8-35

    To further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov records NCT00129259 and NCT00965458).

    at UCSF

  • Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes

    open to eligible people ages 18 years and up

    The overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based, culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to help determine what sequence of intervention strategies work most efficiently and for whom.

    at UCLA

  • Walnuts to Achieve Lasting NUTrition to Prevent Diabetes

    open to eligible people ages 18-65

    Prediabetes is a precursor of type 2 diabetes and an independent risk factor for cardiovascular disease, and currently affects one-quarter of the population of the United States. Individuals of overweight or obese BMI are at particular high risk for incident diabetes. A major modifiable risk factor for type 2 diabetes is poor dietary quality, and improvement of dietary quality can effectively delay and even prevent type 2 diabetes. Interventions to improve dietary quality thus far, however, rely on short-term intensive clinically designed meals replacing the entire diet which have poor sustainability. Persistent improvements to daily dietary patterns are often difficult without directed guidance, and overall dietary quality in the United States remains poor. The identification of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in those at high risk remains unknown. The investigators propose to enroll 40 individuals with diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut supplementation intervention to determine feasibility and acceptability of the supplement. The investigators will then determine preliminary efficacy on metabolic markers and will investigate associations between dietary quality and circulating levels of branched-chain amino acids. The goal is to implement a whole-food supplement to improve dietary quality in patients with prediabetes as a tool for future type 2 diabetes prevention.

    at UCSF

  • A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program

    Sorry, in progress, not accepting new patients

    This proposed project will translate evidence-based strategies for diabetes prevention within the framework of an existing and highly utilized pharmacist-led diabetes care program. Our team includes investigators and practitioners with experience in implementing the DPP (Diabetes Prevention Program) as well as in community-based research. This proposal represents an opportunity to rapidly implement an innovative project addressing a critical area of significant unmet need, as the required key health system and community infrastructure are already in place. The intended outcome is the creation of a practical, effective and sustainable approach to increase evidence-based diabetes prevention strategies that can readily be adopted in other systems.

    at UCLA

  • A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

    Sorry, in progress, not accepting new patients

    The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)

    at UCSF

  • A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

    Sorry, accepting new patients by invitation only

    A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

    at UCSD

  • A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

    Sorry, not currently recruiting here

    A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

    at UCSD

  • A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

    Sorry, in progress, not accepting new patients

    The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.

    at UCSD

  • A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

    at UCSF

  • A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D)

    Sorry, not currently recruiting here

    The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants who recently developed Type 1 Diabetes Mellitus (T1D).

    at UCSF

  • Administration of Low-dose IL-2 in Established T1D

    Sorry, not yet accepting patients

    Randomized, controlled, double blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and to test whether low-dose IL-2 can prevent further loss of beta-cell function in patients with established T1D, or even potentially improve ß-cell function in such individuals, when IL-2 is given for one year (primary outcome). Equally important, the study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.

    at UCSF

  • ATG-GCSF in New Onset Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). The primary objective of the study will be to determine the safety and ability of low dose ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D patients demonstrating residual beta cell function.

    at UCSF

  • Behavioral Economics Applications to Geriatrics Leveraging EHRs

    Sorry, not yet accepting patients

    The risks and benefits of many diagnostic approaches and treatments differ for older adults compared to middle aged adults. When diagnostic and therapeutic strategies are misapplied to older adults this can lead to increased morbidity and mortality. Well established examples where clinicians do not often follow best practices in the care of older adults include those identified by the American Geriatrics Society for the Choosing Wisely initiative: 1) testing and treatment for asymptomatic bacteriuria, 2) prostate specific antigen testing in older men without prostate cancer, and 3) overuse of insulin or oral hypoglycemics for type 2 diabetes. Clinical decision support nudges, informed by social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services in cases where optimal utilization may not be zero but should be well below current practice. These interventions seek to influence conscious and unconscious drivers of clinical decision making, are low cost to implement and disseminate, and can be incorporated into existing delivery systems. In the R21 phase of this Behavioral Economics Applications to Geriatrics Leveraging EHRs (BEAGLE) study, we will: select EHR delivered nudges to address 3 topics of potential misuse in older adults based on the main psychological drivers of overuse identified in interviews with high-using clinicians; develop and pilot test decision support tools within a health systems' EHR to understand technical feasibility, work flow fit, preliminary impact on clinical outcomes, and clinician acceptability; and develop and validate electronic clinical quality measures of potential overuse/misuse related to the care of older adults.

    at UCLA

  • De Novo Lipogenesis, Lipid and Carbohydrate Metabolism in Non-alcoholic Fatty Liver Disease

    Sorry, in progress, not accepting new patients

    The worldwide epidemic of obesity is paralleled with increased cases of non-alcoholic liver disease (liver fat accumulation) and diabetes. Fat belongs in the adipose tissue, and if excess fat accumulates in the liver or muscle, these tissues cannot use sugar efficiently. It has been discovered that when large quantities of fructose (a sugar present in soft drinks) are consumed, the conversion of carbohydrate (CHO) to fat in the liver increases. We hypothesize that: 1) subjects with fatty liver have a higher CHO uptake and conversion to fat in their liver when compared to matched control subjects with normal liver fat content; and that: 2) when subjects with fatty liver are fed a diet limiting fructose and simple sugars will decrease their liver CHO fat content. This reduction in liver fat will normalize the way the liver responds to sugar and insulin, reversing the pre-diabetic state. The measurement of these parameters will be done using state-of-the-art techniques such as safe non-radioactive isotope tracers and non-invasive magnetic resonance spectroscopy. For more information, please call 415-206-5532 for a phone screening

    at UCSF

  • Diabetes and Depression Text Messaging Intervention

    Sorry, not yet accepting patients

    The first goal of the randomized trial will be to study the influence of personalized text messaging on both glycemic control and depressive symptoms. The primary outcomes for this aim will be improvements in physical activity. The secondary outcomes include diabetes and depressive symptoms at the 6-month follow-up, as well as mood and quality of life. The secondary goal of the trial is to evaluate the influence of nurse phone outreach on glycemic control and depressive symptoms for participants who are non-responsive to the text messaging approaches used in this study. In particular, a sequential multiple assignment randomized trial (SMART) design will use responsiveness data from participants during the course of the study to implement a second randomization step for nurse phone outreach.We will examine the same primary outcome and secondary health behavior outcomes among this sub-group.

    at UCSF

  • Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

    at UCLA UCSF

  • 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

  • Enhancing Self-Management Support in Diabetes Through Patient Engagement

    Sorry, accepting new patients by invitation only

    The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care. SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care. To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.

    at UCSF

  • Epidemiology of Diabetes Interventions and Complications (EDIC)

    Sorry, in progress, not accepting new patients

    OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications. Contemporary prospective data on the evolution of macrovascular and late micro vascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its 13th year of followup. The study is expecting to last until 2016. RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid arteries will be perf o rmed at years 1 and 6 and at study end.

    at UCSD

  • Financial Incentives and Text Messaging to Improve African American Womens' Glycemic Control

    Sorry, in progress, not accepting new patients

    Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. This project will incorporate a) new technology whose use is high among African Americans (cell phone text message reminders), b) support from social networks, and c) strategies from the emerging field of behavioral economics to encourage and support self care behaviors that lead to improvements in diabetes control. In Stage I of the study, the investigators conducted focus groups with women with diabetes and their family members and friends. The investigators used information from these groups to work with a team of community partners to develop recruitment protocols, prepare study documents (including flyers, Frequently Asked Questions sheets, and informed consent forms), and finalize participant surveys. In the next phase of the study the investigators will evaluate ways that friends and family members can use direct support and text messages to improve control of blood sugar for African American women with type 2 diabetes. A team of three people--the Person With Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be assigned at random to one of two groups to compare approaches to improving control of blood sugar. Each team will receive information and resources on improving diabetes control and will be linked by a text messaging program. The intervention team will receive additional text messaging support that may help them improve the PWD's diabetes control.

    at UCLA

  • Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)

    Sorry, in progress, not accepting new patients

    The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).

    at UCSF

  • Improving Islet Transplantation Outcomes With Gastrin

    Sorry, not yet accepting patients

    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 Islet cell transplantation involves transplanting the cells that make insulin from a pancreas of deceased organ donor to a patient with diabetes. Because there is a limited supply of donor islet cells available, this study is testing whether Gastrin injections can help make a fewer number of transplanted islets work better. Gastrin is a natural gut hormone that is present in the pancreas during its development in the embryo but not after birth, and is believed to participate in the formation of the normal pancreas. Several studies have tried to use gastrin to help grow insulin making islet cells in laboratory experiments or after transplanting islets in laboratory animals. In early clinical trials, diabetic patients treated with gastrin and other growth factors required less insulin after 4 weeks of gastrin treatment and the effect lasted more than 12 weeks after stopping treatment, suggesting that gastrin may have increased the number of cells that make insulin. This study will evaluate whether taking Gastrin injections following a single islet transplantation is safe, improves how well the islet transplant works and/or helps increase the number of insulin-making cells in the islets. Qualified participants will receive treatment with a single islet transplant, followed by two rounds of gastrin treatment (twice daily injections for 30 days) just after transplant and again 6 months later. Study participants will also take anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support their health and/or the health of the transplanted islets. Participants will need to return to City of Hope in Duarte, CA for frequent follow-up visits for one year after transplant.

    at UCLA

  • Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

    Sorry, not yet accepting patients

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

    at UCLA

  • Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

    Sorry, not currently recruiting here

    Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.

    at UCSD

  • Metabolomic Profiling in Adolescents With Obesity and Diabetes

    Sorry, in progress, not accepting new patients

    The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children. We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.

    at UCSD

  • Multi-component Intervention for Diabetes in Adults With Serious Mental Illness

    Sorry, in progress, not accepting new patients

    Persons with schizophrenia and other serious mental illnesses have a high risk for type 2 diabetes and an increased risk of premature mortality compared to the general population. The goals of the proposed study are to implement a multimodal lifestyle intervention to reduce that risk in these individuals living in residential care facilities, a common housing modality for people with serious mental illnesses. If successful, this intervention will lead to reduction in excess medical comorbidity and mortality in persons with serious mental illnesses.

    at UCSD

  • Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

    Sorry, in progress, not accepting new patients

    Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA). The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.

    at UCSF

  • PASOS: Improving the Health of Immigrant Workers

    Sorry, in progress, not accepting new patients

    This is a cluster randomized trial (CRT) to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.

    at UC Davis

  • Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease management and glycemic control; poor glycemic control can also have a negative effect on DD. Few interventions have been assessed that directly target DD or mood in adults with Type 1 diabetes. In this study the investigators will compare two active, evidence-based behavioral interventions to reduce high DD and improve glycemic control and disease management: 1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management. 2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes. Participants in both arms will attend a single, day-long workshop, four hour-long web group meetings and four personal phone calls with the group facilitator during the intervention period. Assessments will be carried out at baseline and at three and nine months. Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at follow-up. Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the difference between the two study arms and primary outcome. Hypothesis 3: The differences between the two study arms and changes in the primary outcomes will be qualified by patient characteristics such as age, length of diagnosis, higher baseline distress or HbA1c.

    at UCSF

  • Reversing Type 1 Diabetes After it is Established

    Sorry, in progress, not accepting new patients

    The primary purpose of this study is to determine if giving the combination therapy consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1 Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.

    at UCSF

  • Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

    Sorry, in progress, not accepting new patients

    This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.

    at UCSF

  • Social Engagement Strategies to Improve Medication Adherence

    Sorry, not yet accepting patients

    In this pilot study, investigators, in partnership with Resource Centers for Minority Aging Research (RCMAR) mentorship team and the MyMeds program, will enroll patients from MyMeds with diabetes, atherosclerotic cardiovascular disease, or congestive heart failure with poor medication adherence (medication adherence percentage<80% for statin or antihypertensive therapy) who report having a least one loved one or friend (e.g., spouse) whom they consider to be invested in their health, and with whom they would be willing to share focused medical information about medication adherence in the form of text messages. They will randomize these patients to private feedback about medication adherence or social network feedback about medication adherence. Investigators will evaluate the effects of this social network intervention on medication adherence and examine the program's acceptability among study participants. This proposal is innovative because it leverages social networks—largely unused in medical care—for health improvement.

    at UCLA

  • Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

    Sorry, in progress, not accepting new patients

    The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 5-7 years.

    at UCLA UCSF

  • Studying the Effectiveness of Non-Invasive Glucose Sensors in Patients With Diabetes: The SENSOR Study

    Sorry, currently not accepting new patients, but might later

    The overall goal for this pilot clinical trial is to explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings with glucometer measurements from patients with type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.

    at UCSD

  • Telemedicine in Pediatric Type 1 Diabetes

    “Are frequent clinic visits to manage Type 1 Diabetes difficult for you to accommodate? Telemedicine may be a convenient alternative!”

    Sorry, in progress, not accepting new patients

    At the conclusion of this project, investigators will have assessed the effectiveness of home-based telemedicine for improving multiple important clinical and patient-centered outcomes in a high-risk pediatric cohort with T1D. Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic. Specifically: A) Patients and families choose to participate in telemedicine visits as a supplement to in-person care; B) Patients and families can utilize secure, internet-based platforms to upload and share glucose meter data and to establish an audio-video connection with a diabetes specialist in their home settings; C) Patients and families are satisfied with the experience of home-based telemedicine and would choose to receive future diabetes care via this modality. Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete more frequent visits with a diabetes specialist than they previously completed via office visits alone. Aim 3. To test the hypothesis that increased contact with a diabetes specialist via home-based telemedicine will lead to significant improvement in glycemic control for these patients. Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based telemedicine on high-cost health care utilization - specifically emergency department (ED) visits and diabetes-related hospitalizations.

    at UC Davis

  • Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

    Sorry, in progress, not accepting new patients

    The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.

    at UCSF

  • The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children

    Sorry, in progress, not accepting new patients

    This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).

    at UCSD

  • Tocilizumab (TCZ) in New-onset Type 1 Diabetes

    Sorry, in progress, not accepting new patients

    Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control. Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.

    at UCSF

  • Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads

    Sorry, accepting new patients by invitation only

    Mexican American women have significantly elevated rates of obesity and type 2 diabetes. The proposed study tests a novel intervention that capitalizes on an existing important family dyad (mothers and their adult daughters) to foster clinically significant and long-lasting health behavior change. If found to effective, this intervention strategy has great potential to address health disparities in this, and other, at-risk populations.

    at UC Irvine UCSD

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