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NCT06525259Recruiting

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

George Washington University

Start Date

10/1/2024

Completion Date

1/31/2028

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 Criteria

Age Range: 8 years to 15 years

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

Diabetes Mellitus Type 2, Childhood-Onset

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Arizona State University

Phoenix, Arizona 85004

United States

Phoenix Children's

Phoenix, Arizona 85006

United States

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida 33701

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland 21287

United States

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

Boston, Massachusetts 02215

United States

Colorado Navajo Nation

Shiprock, New Mexico 87420

United States

NYU Langone Health- Brooklyn

Brooklyn, New York 11220

United States

NYU Langone Health- Long Island

Garden City, New York 11530

United States

NYU Langone Health- Manhattan

New York, New York 10016

United States

Albert Einstein College of Medicine

The Bronx, New York 10461

United States

Atrium Health

Charlotte, North Carolina 28207

United States

Wake Forest University

Winston-Salem, North Carolina 27157

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Baylor College of Medicine / Texas Children's

Houston, Texas 77030

United States