NCT06525259 DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
| NCT ID | NCT06525259 |
| Status | Recruiting |
| Phase | — |
| Sponsor | George Washington University |
| Condition | Diabetes Mellitus Type 2, Childhood-Onset |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,600 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,600 participants in total. It began in 2024-10-01 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06525259 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 15 Years, studying Diabetes Mellitus Type 2, Childhood-Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06525259 currently recruiting?
Yes, NCT06525259 is actively recruiting participants. Contact the research team at braffett@bsc.gwu.edu for enrollment information.
Where is the NCT06525259 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Phoenix, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06525259 clinical trial?
NCT06525259 is sponsored by George Washington University. The trial plans to enroll 3,600 participants.
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