Identifying Risk Factors for Type 2 Diabetes in Young People

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Study contacts

• Study coordinator: Barbara Braffett, PhD
• Email: braffett@bsc.gwu.edu
• Phone: 3018819260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.