DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Recruiting now

Conditions studied: Diabetes Mellitus Type 2, Childhood-Onset

In brief

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.

Key facts

Study ID

NCT06525259

Run by

George Washington University

People needed

3600

Starts

2024-10-01

Expected to finish

2028-01-31

Last updated by the study team

2026-05-07

Who can join

Age: 8 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Arizona State University — Phoenix, Arizona, United States (enrolling)
• Phoenix Children's — Phoenix, Arizona, United States (enrolling)
• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
• Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Colorado Navajo Nation — Shiprock, New Mexico, United States (enrolling)
• NYU Langone Health- Brooklyn — Brooklyn, New York, United States (enrolling)
• NYU Langone Health- Long Island — Garden City, New York, United States (enrolling)
• NYU Langone Health- Manhattan — New York, New York, United States (enrolling)
• Albert Einstein College of Medicine — The Bronx, New York, United States (enrolling)
• Atrium Health — Charlotte, North Carolina, United States (enrolling)
• Wake Forest University — Winston-Salem, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Baylor College of Medicine / Texas Children's — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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