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DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

RECRUITING

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.

I'm interested

ALL
8 years to 15 years old

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

Diabetes Mellitus Type 2, Childhood-Onset

Hailey Eisenmann - discoveryinteens@cchmc.org
NCT06525259
See this study on ClinicalTrials.gov

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