DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
Recruiting · NCT06525259 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
8 Years to 15 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
20 locations listed across 14 US states.
- 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
- 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
- Albert Einstein College of Medicine - The Bronx, 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