Summary

Eligibility
for people ages 8-15 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Shylaja Srinivasan (ucsf)
Headshot of Shylaja Srinivasan
Shylaja Srinivasan

Description

Summary

The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.

Details

The DISCOVERY study will extensively phenotype a large cohort of youth at-risk for type 2 diabetes, as they transition through puberty, and characterize the course of dysfunction in pathophysiological indicators that lead to type 2 diabetes. The knowledge gained from this study of the pathophysiology and epidemiology of youth-onset type 2 diabetes with deep biochemical, clinical, and psychosocial phenotyping will critically inform the design and testing of future treatment and prevention approaches.

Keywords

Diabetes Mellitus Type 2, Childhood-Onset, Type 2 Diabetes Mellitus

Eligibility

You can join if…

Open to people ages 8-15

Screening will occur to enrich the yield of individuals who are highly predisposed to develop youth-onset T2D and include those with all of the following criteria:

  • Overweight or obesity with BMI ≥85th percentile
  • Age 8-13 year for girls, 9-15 year for boys (inclusion younger for girls as puberty tends to start a year earlier in girls)
  • Tanner Stage 2, 3, or 4
  • Elevated HbA1c 5.5-6.4%

You CAN'T join if...

An individual who meets any of the following criteria will be excluded from participation:

  • Diabetes based on history, or HbA1c ≥6.5% in the medical record or at screening
  • Unable/unwilling to provide consent/participate fully
  • Conditions predisposing to diabetes or altering the trajectory of puberty
  • Medications affecting glucose dynamics during the screening and enrollment period
  • Prior treatment with insulin
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications in the 6 weeks prior to enrollment
  • Planning treatment with glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications
  • Use of metformin or any glucose lowering medication for a reason other than treatment of diabetes (e.g., for PCOS) in the 6 weeks prior to enrollment
  • Planning treatment with metformin or any glucose lowering medication or planning to use such medications for a reason other than treatment of diabetes (e.g., for PCOS)
  • Known syndromic/monogenic obesity
  • Blood disorders impacting HbA1c (e.g., anemia, hemoglobin variants)
  • Major systemic organ disease
  • History of bariatric surgery or currently planning bariatric surgery
  • Current pregnancy or currently planning pregnancy
  • Use of GnRH agonist, estrogen, or testosterone
  • Individuals who do not speak English or Spanish, given validation of the questionnaires to be utilized

Locations

  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Arizona State University accepting new patients
    Phoenix Arizona 85004 United States
  • Phoenix Children's accepting new patients
    Phoenix Arizona 85006 United States

Lead Scientist at University of California Health

  • Shylaja Srinivasan (ucsf)
    I am a physician-scientist and Associate Professor of Pediatrics in the Division of Pediatric Endocrinology at UCSF. My clinical and scientific focus is on prediabetes and type 2 diabetes in youth. Specifically, I use pharmacologic and genetic approaches to evaluate pathophysiology and therapeutic strategies for youth with prediabetes and type 2 diabetes.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
George Washington University
ID
NCT06525259
Study Type
Observational
Participants
Expecting 3600 study participants
Last Updated