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DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

RECRUITINGSponsored by George Washington University
Actively Recruiting
SponsorGeorge Washington University
Started2024-10-01
Est. completion2028-01-31
Eligibility
Age8 Years – 15 Years
Locations20 sites

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.

Eligibility

Age: 8 Years – 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

Conditions2

DiabetesDiabetes Mellitus Type 2, Childhood-Onset

Locations20 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Adrienna Stephens205-975-6579discovery@uab.edu
Arizona State University
Phoenix, Arizona, 85004
Irene Marquez602-496-0147imarqu13@asu.edu
Phoenix Children's
Phoenix, Arizona, 85006
Lynette B Davis602-933-6359Ldavis8@phoenixchildrens.com
Children's Hospital Los Angeles
Los Angeles, California, 90027
Leticia Eufracio323-497-5088leufracio@chla.usc.edu
Children's Hospital Colorado
Aurora, Colorado, 80045
Kelly Wiitala720-777-2855DISCOVERY@childrenscolorado.org

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