Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3600 participants
OBSERVATIONAL
2024-10-01
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
9 Years
14 Years
ALL
No
Sponsors
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George Washington University
OTHER
Responsible Party
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Barbara Braffett
Associate Professor
Locations
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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
NYU Langone Health- Long Island
Garden City, New York, United States
NYU Langone Health- Manhattan
New York, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Baylor College of Medicine / Texas Children's
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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