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DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
NCT06525259 · George Washington University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
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 design
Enrollment target: 3600 participants
Age groups: child
Timeline
Starts: 2024-10-01
Estimated completion: 2028-01-31
Last updated: 2026-03-05
Primary outcomes
- • Type 2 diabetes (Through study completion, an average of 2.5 years)
Sponsor
George Washington University · other
Contacts & investigators
ContactBarbara Braffett, PhD · contact · braffett@bsc.gwu.edu · 3018819260
ContactBrian Burke, MS · contact · bburke@bsc.gwu.edu · 3018819260
All locations (20)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Arizona State UniversityRecruiting
Phoenix, Arizona, United States
Phoenix Children'sRecruiting
Phoenix, Arizona, United States
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States
Children's Hospital ColoradoRecruiting
Aurora, Colorado, United States
Johns Hopkins All Children's HospitalRecruiting
St. Petersburg, Florida, United States
Johns Hopkins University School of MedicineRecruiting
Baltimore, Maryland, United States
Boston Children's/Joslin Diabetes Center/Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Colorado Navajo NationRecruiting
Shiprock, New Mexico, United States
NYU Langone Health- BrooklynRecruiting
Brooklyn, New York, United States
NYU Langone Health- Long IslandRecruiting
Garden City, New York, United States
NYU Langone Health- ManhattanRecruiting
New York, New York, United States
Albert Einstein College of MedicineRecruiting
The Bronx, New York, United States
Atrium HealthRecruiting
Charlotte, North Carolina, United States
Wake Forest UniversityRecruiting
Winston-Salem, North Carolina, United States
Cincinnati Children's HospitalRecruiting
Cincinnati, Ohio, United States
Nationwide Children's HospitalRecruiting
Columbus, Ohio, United States
The University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Baylor College of Medicine / Texas Children'sRecruiting
Houston, Texas, United States