DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
- Conditions
- Diabetes Mellitus Type 2, Childhood-Onset
- Registration Number
- NCT06525259
- Lead Sponsor
- George Washington University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3600
Screening will occur to enrich the yield of individuals who are highly predisposed to develop youth-onset type 2 diabetes and include those with all of the criteria in Category A:
- Overweight or obesity with BMI ≥85th percentile
- Age 9-13 year for girls, 10-14 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%
Participants who meet all of these categories will further need to meet at least one criterion in Category B:
- Family history of type 2 diabetes in 1st or 2nd degree relative
- Personal exposure to maternal diabetes (i.e., gestational diabetes mellitus (GDM) or mother with type 1 or type 2 diabetes while pregnant with participant)
- HbA1c ≥6.0%
- Severe obesity (BMI ≥99th percentile)
- Personal history of intrauterine growth restriction (IUGR), small for gestational age (SGA), or low birth weight
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 (transplant, cancer, Down Syndrome, Turner Syndrome, Klinefelter Syndrome, ovarian/testicular failure, etc.)
- Medications affecting glucose dynamics during the screening and enrollment period (oral steroids, inhaled steroids >1,000mcg/day past month, atypical antipsychotics, topiramate)
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type 2 diabetes Through study completion, an average of 2.5 years Development of type 2 diabetes, as defined by a hemoglobin A1c (HbA1c) ≥6.5% at an annual or mid-year visit followed by a confirmatory HbA1c ≥6.5% collected within 2 weeks of the first value.
- Secondary Outcome Measures
Name Time Method Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux Through study completion, an average of 2.5 years Intermediary changes in glycemia, β-cell function, insulin sensitivity, and free fatty acid flux along the spectrum of normal glycemia to prediabetes to type 2 diabetes.
Trial Locations
- Locations (20)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona State University
🇺🇸Phoenix, Arizona, United States
Phoenix Children's
🇺🇸Phoenix, Arizona, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Colorado Navajo Nation
🇺🇸Shiprock, New Mexico, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
NYU Langone Health- Brooklyn
🇺🇸Brooklyn, New York, United States
NYU Langone Health- Long Island
🇺🇸Garden City, New York, United States
NYU Langone Health- Manhattan
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Wake Forest University
🇺🇸Winston Salem, North Carolina, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine / Texas Children's
🇺🇸Houston, Texas, United States