Diabetes Mellitus Type 2, Childhood-OnsetDISCOVERYNCT06525259
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
An observational study of Diabetes Mellitus Type 2, Childhood-Onset, run by George Washington University at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Childhood-Onset
- How many people
- 3,600 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Oct 2024to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Child
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.
Who may be able to join
- 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%
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Kelly Wiitala, 720-777-2855, DISCOVERY@childrenscolorado.org
Kristen Nadeau, MD
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Benjamin Potts, 443-287-8997, bpotts2@jh.edu
Sheela N Magge, MD, MSCE
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Laura Lee Goree, 205-934-4386, discovery@uab.edu
Barbara Gower, PhD
- Recruiting
Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital
Boston, Massachusetts, 02215
Jackson Tu, 617-309-4193, DISCOVERYTeam@joslin.harvard.edu
Elvira Isganaitis, MD, MPH
- Recruiting
NYU Langone Health- Brooklyn
Brooklyn, New York, 11220
Celia Engelson, 929-731-2272, DiscoveryStudyBrooklyn@nyulangone.org
Mary Pat Gallagher, MD
- Recruiting
Atrium Health
Charlotte, North Carolina, 28207
Merischia Griffin, 704-446-4804, pediatricresearch@atriumhealth.org
Christine Turley, MD
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Hailey Eisenmann, 513-803-6708, discoveryinteens@cchmc.org
Allen Riegler, Allen.Riegler@cchmc.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Jacqueline Brito, 614-722-8528, Jacqueline.brito@nationwidechildrens.org
Robert P Hoffman, MD
- Recruiting
NYU Langone Health- Long Island
Garden City, New York, 11530
Marilyn Richardson, 516-969-6120, DiscoveryStudyLI@nyulangone.org
Alan Jacobson, MD
- Recruiting
Baylor College of Medicine / Texas Children's
Houston, Texas, 77030
Jesus Cazares, 713-798-7132, jesus.cazares@bcm.edu
Dahlia Solorzano, 713-798-7125, dahlia.solorzano@bcm.edu
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Leticia Eufracio, 323-497-5088, leufracio@chla.usc.edu
Michael Goran, PhD
- Recruiting
NYU Langone Health- Manhattan
New York, New York, 10016
Laura March, 929-731-2272, DiscoveryStudyManhattan@nyulangone.org
Mary Pat Gallagher, MD
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Jeff Preske, 405-271-7554, discoverystudy@ou.edu
Jeanie B Tryggestad, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Sarah Loughran, 215-590-2134, DISCOVERYSTUDY@CHOP.EDU
Beth Schwartzman, schwartzmann@chop.edu
- Recruiting
Arizona State University
Phoenix, Arizona, 85004
Irene Marquez, 602-496-0147, imarqu13@asu.edu
Gabriel Shaibi, PhD
- Recruiting
Phoenix Children's
Phoenix, Arizona, 85006
Lynette B Davis, 602-933-6359, Ldavis8@phoenixchildrens.com
Melissa Chambers, DO
- Recruiting
Colorado Navajo Nation
Shiprock, New Mexico, 87420
Melanie Aspaas, 720-957-5074, melanie.aspaas@cuanschutz.edu
Dana Dabelea, MD, PhD
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Antonika Ford, 727-898-4895, aford38@jh.edu
Sheela N Magge, MD, MSCE
- Recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
Nicole Maysonet, 347-949-3964, einstein-discoverystudy@einsteinmed.edu
Carmen R Isasi, MD, PhD
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27157
Alisha Davis, 336-713-3132, Discovery_Study@wakehealth.edu
Elizabeth Jensen, PhD
About this study
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.
Read the 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.
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes
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.
Measured: Through study completion, an average of 2.5 years
Secondary outcomes (1)
Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux
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.
Measured: Through study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2, Childhood-OnsetStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Braffett, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525259
- Sponsor's protocol ID
- U01DK134971
- Acronym
- DISCOVERY
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2024
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
- ClinicalTrials.gov ID
- NCT06525259
- Acronym / sponsor ID
- DISCOVERY / U01DK134971
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux
Time frame: Through study completion, an average of 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, Childhood-Onset, run by George Washington University at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Braffett, PhD (3018819260, braffett@bsc.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes (time frame: Through study completion, an average of 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.