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Recruiting NCT06525259

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

— Observational Diabetes Mellitus Type 2, Childhood-Onset

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2, Childhood-Onset. Basic parameters: 8 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

The DISCOVERY study will extensively phenotype a large cohort of youth at-risk for type 2 diabetes, as they transition through puberty, and characterize the course of dysfunction in pathophysiological indicators that lead to type 2 diabetes. The knowledge gained from this study of the pathophysiology and epidemiology of youth-onset type 2 diabetes with deep biochemical, clinical, and psychosocial phenotyping will critically inform the design and testing of future treatment and prevention approaches.

Primary outcome measures

  • Type 2 diabetes [Time frame: Through study completion, an average of 2.5 years]
Secondary outcome measures (1)
  • Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux [Time frame: Through study completion, an average of 2.5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 20 centers
  • University of Alabama at Birmingham — Birmingham
  • Arizona State University — Phoenix
  • Phoenix Children's — Phoenix
  • Children's Hospital Los Angeles — Los Angeles
  • Children's Hospital Colorado — Aurora
  • Johns Hopkins All Children's Hospital — St. Petersburg
  • Johns Hopkins University School of Medicine — Baltimore
  • Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital — Boston
  • … and 12 more centers

Identifiers

NCT: NCT06525259 · U01DK134971

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗