Status:
RECRUITING
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
Lead Sponsor:
George Washington University
Conditions:
Diabetes Mellitus Type 2, Childhood-Onset
Eligibility:
All Genders
9-14 years
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 ...
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...
Eligibility Criteria
Inclusion
- Screening will occur to enrich the yield of individuals who are highly predisposed to develop youth-onset type 2 diabetes and include those with all of the criteria in Category A:
- Overweight or obesity with BMI ≥85th percentile
- Age 9-13 year for girls, 10-14 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%
- Participants who meet all of these categories will further need to meet at least one criterion in Category B:
- Family history of type 2 diabetes in 1st or 2nd degree relative
- Personal exposure to maternal diabetes (i.e., gestational diabetes mellitus (GDM) or mother with type 1 or type 2 diabetes while pregnant with participant)
- HbA1c ≥6.0%
- Severe obesity (BMI ≥99th percentile)
- Personal history of intrauterine growth restriction (IUGR), small for gestational age (SGA), or low birth weight
Exclusion
- 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 (transplant, cancer, Down Syndrome, Turner Syndrome, Klinefelter Syndrome, ovarian/testicular failure, etc.)
- Medications affecting glucose dynamics during the screening and enrollment period (oral steroids, inhaled steroids \>1,000mcg/day past month, atypical antipsychotics, topiramate)
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
3600 Patients enrolled
Trial Details
Trial ID
NCT06525259
Start Date
October 1 2024
End Date
January 31 2028
Last Update
May 9 2025
Active Locations (20)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona State University
Phoenix, Arizona, United States, 85004
3
Phoenix Children's
Phoenix, Arizona, United States, 85006
4
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027