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DISCOVERY of Risk Factors for Type 2 Diabetes in Youth | Clinical Trials | Clareo Health

RECRUITING

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

NCT06525259•George Washington University

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.

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.

Eligibility

Age

8 - 15 years

Sex

ALL

Healthy Volunteers

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)
+7 more criteria

Locations (20)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona State University

Phoenix, Arizona, United States

Phoenix Children's

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

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

Boston, Massachusetts, United States

Colorado Navajo Nation

Shiprock, New Mexico, United States

NYU Langone Health- Brooklyn

Brooklyn, New York, United States

Key Dates

Start Date

October 1, 2024

Primary Completion Date

January 31, 2028

Completion Date

January 31, 2028

Last Updated

March 5, 2026

Enrollment

3,600

ESTIMATED participants

Conditions

Diabetes Mellitus Type 2, Childhood-Onset

Contacts

Barbara Braffett, PhD

CONTACT

3018819260 braffett@bsc.gwu.edu

Brian Burke, MS

CONTACT

3018819260 bburke@bsc.gwu.edu