Recruiting

Observational StudyDISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Sponsor:

George Washington University

Code:

NCT06525259

Conditions

Diabetes Mellitus Type 2, Childhood-Onset

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Diabetes Mellitus Type 2, Childhood-Onset

Study ID

NCT06525259

Start date

Oct 1, 2024

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

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 Design

Enrollment

3600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Type 2 diabetes [ Time Frame: Through study completion, an average of 2.5 years ]

Central Contacts and Locations

Central contacts

Barbara Braffett, PhD

3018819260 braffett@bsc.gwu.edu

Brian Burke, MS

3018819260 bburke@bsc.gwu.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Laura Lee Goree

205-934-4386 discovery@uab.edu

Principal Investigator:

Barbara Gower, PhD

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Irene Marquez

602-496-0147 imarqu13@asu.edu

Principal Investigator:

Gabriel Shaibi, PhD

Phoenix Children's

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Lynette B Davis

602-933-6359 Ldavis8@phoenixchildrens.com

Principal Investigator:

Melissa Chambers, DO

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Leticia Eufracio

323-497-5088 leufracio@chla.usc.edu

Principal Investigator:

Michael Goran, PhD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kelly Wiitala

720-777-2855 DISCOVERY@childrenscolorado.org

Principal Investigator:

Kristen Nadeau, MD

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Antonika Ford

727-898-4895 aford38@jh.edu

Principal Investigator:

Sheela N Magge, MD, MSCE

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Benjamin Potts

443-287-8997 bpotts2@jh.edu

Principal Investigator:

Sheela N Magge, MD, MSCE

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

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jackson Tu

617-309-4193 DISCOVERYTeam@joslin.harvard.edu

Principal Investigator:

Elvira Isganaitis, MD, MPH

Colorado Navajo Nation

Recruiting

Shiprock, New Mexico, United States, 87420

Contacts

Melanie Aspaas

720-957-5074 melanie.aspaas@cuanschutz.edu

Principal Investigator:

Dana Dabelea, MD, PhD

NYU Langone Health- Brooklyn

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Celia Engelson

929-731-2272 DiscoveryStudyBrooklyn@nyulangone.org

Principal Investigator:

Mary Pat Gallagher, MD

NYU Langone Health- Long Island

Recruiting

Garden City, New York, United States, 11530

Contacts

Marilyn Richardson

516-969-6120 DiscoveryStudyLI@nyulangone.org

Principal Investigator:

Alan Jacobson, MD

NYU Langone Health- Manhattan

Recruiting

New York, New York, United States, 10016

Contacts

Laura March

929-731-2272 DiscoveryStudyManhattan@nyulangone.org

Principal Investigator:

Mary Pat Gallagher, MD

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Nicole Maysonet

347-949-3964 einstein-discoverystudy@einsteinmed.edu

Principal Investigator:

Carmen R Isasi, MD, PhD

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Merischia Griffin

704-446-4804 pediatricresearch@atriumhealth.org

Principal Investigator:

Christine Turley, MD

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Alisha Davis

336-713-3132 Discovery_Study@wakehealth.edu

Principal Investigator:

Elizabeth Jensen, PhD

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Hailey Eisenmann

513-803-6708 discoveryinteens@cchmc.org

Allen Riegler

Allen.Riegler@cchmc.org

Principal Investigator:

Amy S Shah, MD, MS

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Jacqueline Brito

614-722-8528 Jacqueline.brito@nationwidechildrens.org

Principal Investigator:

Robert P Hoffman, MD

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Jeff Preske

405-271-7554 discoverystudy@ou.edu

Principal Investigator:

Jeanie B Tryggestad, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sarah Loughran

215-590-2134 DISCOVERYSTUDY@CHOP.EDU

Beth Schwartzman

schwartzmann@chop.edu

Principal Investigator:

Lorraine E Levitt Katz, MD

Baylor College of Medicine / Texas Children's

Recruiting

Houston, Texas, United States, 77030

Contacts

Jesus Cazares

713-798-7132 jesus.cazares@bcm.edu

Dahlia Solorzano

713-798-7125 dahlia.solorzano@bcm.edu

Principal Investigator:

Fida Bacha, MD

More Information

Sponsor

George Washington University

Last update posted

May 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by George Washington University on 2026-05-07.