Identifying Risk Factors for Type 2 Diabetes in Young People
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
This study looks at young people who are overweight to see what factors might lead them to develop type 2 diabetes as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | 8 Years to 15 Years |
| Sex | All |
| Sponsor | George Washington University Academic / other |
| Locations | 20 sites (Birmingham, Alabama and 19 other locations) |
| Trial ID | NCT06525259 on ClinicalTrials.gov |
What this trial studies
The DISCOVERY study aims to investigate the natural history of glycemic control, insulin sensitivity, and β-cell function in obese adolescents at risk for developing type 2 diabetes. This observational study will phenotype a large cohort of youth as they transition through puberty, focusing on the pathophysiological indicators that lead to type 2 diabetes. By gathering deep biochemical, clinical, and psychosocial data, the study seeks to enhance understanding of youth-onset type 2 diabetes and inform future treatment and prevention strategies.
Who should consider this trial
Good fit: Ideal candidates are obese adolescents aged 9-14 years with specific risk factors for type 2 diabetes.
Not a fit: Patients who do not meet the inclusion criteria or have conditions unrelated to type 2 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for type 2 diabetes in adolescents.
How similar studies have performed: Other studies have shown success in identifying risk factors for type 2 diabetes in youth, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 19 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Arizona State University — Phoenix, Arizona, United States (Recruiting)
- Phoenix Children's — Phoenix, Arizona, United States (Recruiting)
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Recruiting)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Colorado Navajo Nation — Shiprock, New Mexico, United States (Recruiting)
- NYU Langone Health- Brooklyn — Brooklyn, New York, United States (Recruiting)
- NYU Langone Health- Long Island — Garden City, New York, United States (Recruiting)
- NYU Langone Health- Manhattan — New York, New York, United States (Recruiting)
- Albert Einstein College of Medicine — The Bronx, New York, United States (Recruiting)
- Atrium Health — Charlotte, North Carolina, United States (Recruiting)
- Wake Forest University — Winston-Salem, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Baylor College of Medicine / Texas Children's — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Barbara Braffett, PhD
- Email: braffett@bsc.gwu.edu
- Phone: 3018819260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.