Recruiting
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
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.
ClinicalTrials.gov IDNCT06525259
PhaseNot Applicable
Enrollment3600
SponsorGeorge Washington University
Age8 Years
SexALL
Conditions studied
Diabetes Mellitus Type 2, Childhood-Onset
About this study
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.
Primary outcomes
- Type 2 diabetes (Through study completion, an average of 2.5 years)
Eligibility information
Inclusion Criteria:
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%
Exclusion Criteria:
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
Study locations
- University of Alabama at Birmingham, Birmingham, Alabama 35294 United States
- Arizona State University, Phoenix, Arizona 85004 United States
- Phoenix Children's, Phoenix, Arizona 85006 United States
- Children's Hospital Los Angeles, Los Angeles, California 90027 United States
- Children's Hospital Colorado, Aurora, Colorado 80045 United States
- Johns Hopkins All Children's Hospital, St. Petersburg, Florida 33701 United States
- Johns Hopkins University School of Medicine, Baltimore, Maryland 21287 United States
- Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital, Boston, Massachusetts 02215 United States
- Colorado Navajo Nation, Shiprock, New Mexico 87420 United States
- NYU Langone Health- Brooklyn, Brooklyn, New York 11220 United States
Showing 10 of 20 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.