DISCOVERY of Risk Factors for Type 2 Diabetes in Youth (DISCOVERY)

May 6, 2026 updated by: Barbara Braffett, George Washington University
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Barbara Gower, PhD
        • Principal Investigator:
          • Ambika Ashraf, MD
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Arizona State University
        • Principal Investigator:
          • Gabriel Shaibi, PhD
        • Contact:
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Phoenix Children's
        • Contact:
        • Principal Investigator:
          • Melissa Chambers, DO
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
        • Principal Investigator:
          • Michael Goran, PhD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Kristen Nadeau, MD
        • Principal Investigator:
          • Megan Kelsey, MD
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Sheela N Magge, MD, MSCE
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Sheela N Magge, MD, MSCE
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Elvira Isganaitis, MD, MPH
        • Principal Investigator:
          • Amy Fleischman, MD
        • Principal Investigator:
          • Takara Stanley, MD, PhD
    • New Mexico
      • Shiprock, New Mexico, United States, 87420
        • Recruiting
        • Colorado Navajo Nation
        • Contact:
        • Principal Investigator:
          • Dana Dabelea, MD, PhD
        • Principal Investigator:
          • Wei Perng, PhD, MPH
    • New York
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • NYU Langone Health- Brooklyn
        • Contact:
        • Principal Investigator:
          • Mary Pat Gallagher, MD
        • Principal Investigator:
          • Alan Jacobson, MD
      • Garden City, New York, United States, 11530
        • Recruiting
        • NYU Langone Health- Long Island
        • Contact:
        • Principal Investigator:
          • Alan Jacobson, MD
      • New York, New York, United States, 10016
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Albert Einstein College of Medicine
        • Contact:
        • Principal Investigator:
          • Carmen R Isasi, MD, PhD
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University
        • Contact:
        • Principal Investigator:
          • Elizabeth Jensen, PhD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • Robert P Hoffman, MD
        • Principal Investigator:
          • Ihuoma Eneli, MBBS
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Jeanie B Tryggestad, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorraine E Levitt Katz, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine / Texas Children's
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fida Bacha, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

3,600 youth, aged 8-15 years at enrollment, of all genders and race/ethnic groups from 15 clinical centers in the United States will be included. Youth will be overweight or obese (BMI ≥85th percentile for age) and have evidence of dysglycemia with an HbA1c range from 5.5-6.4% at screening.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 diabetes
Time Frame: Through study completion, an average of 2.5 years
Development of type 2 diabetes, as defined by a hemoglobin A1c (HbA1c) ≥6.5% at an annual or mid-year visit followed by a confirmatory HbA1c ≥6.5% collected within 2 weeks of the first value.
Through study completion, an average of 2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux
Time Frame: Through study completion, an average of 2.5 years
Intermediary changes in glycemia, β-cell function, insulin sensitivity, and free fatty acid flux along the spectrum of normal glycemia to prediabetes to type 2 diabetes.
Through study completion, an average of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01DK134971 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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