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DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 15 Years
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The DISCOVERY study looks at how blood sugar control and the body's ability to make and use insulin change over time. It is for children and teens with extra body weight who are at high risk for type 2 diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have overweight or obesity, with a BMI at or above the 85th percentile for age and sex.
  • Girls ages 8–13 or boys ages 9–15.
  • Have started puberty but have not finished it (Tanner stage 2, 3, or 4).
  • Have an HbA1c of 5.5–6.4%. This blood test measures average blood sugar.

Who can't join

  • Have diabetes or an HbA1c of 6.5% or higher in medical records or at screening.
  • Cannot or do not want to give consent or take part fully, or do not speak English or Spanish.
  • Have a condition that raises diabetes risk or changes puberty, or have obesity caused by a known genetic condition.
  • Have a blood disorder that affects HbA1c results, such as anemia, or a major disease affecting the body's organs.
  • Take medicines that affect blood sugar during screening or enrollment, or have ever used insulin.
  • Used GLP-1 medicines or weight-loss medicines in the past 6 weeks, or plan to use them; used metformin or other blood-sugar-lowering medicines for a reason other than diabetes in the past 6 weeks, or plan to use blood-sugar-lowering medicines.
  • Have had weight-loss surgery or plan to have it, or are pregnant or planning pregnancy.
  • Use GnRH agonists (medicines that affect puberty hormones), estrogen, or testosterone.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (20)

AL

AZ

CA

CO

FL

MA

  • Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital · Boston, MA 02215Jackson Tu · Study contact · 617-309-4193 · DISCOVERYTeam@joslin.harvard.eduElvira Isganaitis, MD, MPH · Principal investigatorAmy Fleischman, MD · Principal investigatorTakara Stanley, MD, PhD · Principal investigatorMore trials in Boston

MD

NC

NM

NY

OH

OK

PA

TX