Actively Recruiting

Age: 8Years - 15Years
All Genders
ID06525259

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Led by George Washington University · Updated on 2026-05-07

3600

Participants Needed

20

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the unique natural history of blood sugar control, insulin sensitivity, and beta-cell function in obese adolescents at risk for developing type 2 diabetes. This observational study aims to understand how these factors and their causes change as youth transition through puberty, providing important information that could help design future treatments and prevention strategies for youth-onset type 2 diabetes. The study will carefully examine a large group of young people at risk for type 2 diabetes using detailed biochemical, clinical, and psychosocial assessments. Participants aged 8 to 15 years who meet specific criteria related to obesity, puberty stage, and blood sugar levels will be observed over an average of 2.5 years. No treatments or medications are being tested; instead, the study focuses on tracking natural changes and risk factors over time. Throughout the study, participants will undergo regular evaluations to monitor blood sugar control, beta-cell function, insulin sensitivity, and fatty acid metabolism. These measures will be collected along with clinical and psychosocial data to better understand the progression toward type 2 diabetes. The research team will review these outcomes continuously during the study period, aiming to improve knowledge about diabetes risk in youth and inform future care approaches.

CONDITIONS

Brief Title

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Who Can Participate

Age: 8Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Overweight or obesity with BMI at or above the 85th percentile
  • Age 8 to 13 years for girls, 9 to 15 years for boys
  • Tanner Stage 2, 3, or 4 of puberty
  • Elevated HbA1c between 5.5% and 6.4%
Not Eligible

You will not qualify if you...

  • History of diabetes or HbA1c 6.5% or higher
  • Unable or unwilling to provide consent or participate fully
  • Conditions that predispose to diabetes or affect puberty progression
  • Use of medications affecting glucose metabolism during screening and enrollment
  • Prior insulin treatment
  • Use or planned use of GLP-1 receptor agonists or weight loss medications within 6 weeks before enrollment
  • Use or planned use of metformin or glucose-lowering drugs for reasons other than diabetes within 6 weeks before enrollment
  • Known syndromic or monogenic obesity
  • Blood disorders affecting HbA1c (e.g., anemia, hemoglobin variants)
  • Major systemic organ disease
  • History of or planned bariatric surgery
  • Current or planned pregnancy
  • Use of GnRH agonist, estrogen, or testosterone
  • Non-English or non-Spanish speakers due to questionnaire validation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 2.5 years

Participants are extensively assessed through biochemical, clinical, and psychosocial measures as they transition through puberty to characterize risk factors and progression toward type 2 diabetes.

Regular visits scheduled throughout the study period

Trial Site Locations

Total: 20 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Arizona State University

Phoenix, Arizona, United States, 85004

Actively Recruiting

3

Phoenix Children's

Phoenix, Arizona, United States, 85006

Actively Recruiting

4

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

5

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

6

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States, 33701

Actively Recruiting

7

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

8

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

Boston, Massachusetts, United States, 02215

Actively Recruiting

9

Colorado Navajo Nation

Shiprock, New Mexico, United States, 87420

Actively Recruiting

10

NYU Langone Health- Brooklyn

Brooklyn, New York, United States, 11220

Actively Recruiting

11

NYU Langone Health- Long Island

Garden City, New York, United States, 11530

Actively Recruiting

12

NYU Langone Health- Manhattan

New York, New York, United States, 10016

Actively Recruiting

13

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

Actively Recruiting

14

Atrium Health

Charlotte, North Carolina, United States, 28207

Actively Recruiting

15

Wake Forest University

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

16

Cincinnati Children's Hospital

Cincinnati, Ohio, United States, 45229

Actively Recruiting

17

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

18

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

19

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

20

Baylor College of Medicine / Texas Children's

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Barbara Braffett, PhD

B

Brian Burke, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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