RecruitingNCT06525259
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
Sponsor
George Washington University
Enrollment
3,600 participants
Start Date
Oct 1, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 8 YearsMax Age: 15 Years
Inclusion Criteria5
- 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 Criteria17
- 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
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06525259