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New study tracks 3,600 teens to uncover diabetes clues

NCT ID NCT06525259

Knowledge-focused Sponsor: George Washington University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 3,600 overweight or obese teenagers who are at high risk for developing type 2 diabetes. Researchers will monitor changes in blood sugar, insulin, and other factors over time to learn how the disease starts. No treatments or medications are given—the goal is simply to gather information to better predict and prevent diabetes in youth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

8 to 15 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2, childhood-onset

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    RECRUITING

    The Bronx, New York, 10461, United States

  • Arizona State University

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28207, United States

    Contact Email: •••••@•••••

  • Baylor College of Medicine / Texas Children's

    RECRUITING

    Houston, Texas, 77030, United States

  • Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Cincinnati Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Colorado Navajo Nation

    RECRUITING

    Shiprock, New Mexico, 87420, United States

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University School of Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • NYU Langone Health- Brooklyn

    RECRUITING

    Brooklyn, New York, 11220, United States

    Contact Email: •••••@•••••

  • NYU Langone Health- Long Island

    RECRUITING

    Garden City, New York, 11530, United States

    Contact Email: •••••@•••••

  • NYU Langone Health- Manhattan

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Phoenix Children's

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • The University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

    Contact Email: •••••@•••••

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Wake Forest University

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.