Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

Completed

• Conditions: Obesity, Childhood; PreDiabetes

• Registration Number: NCT05055219
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2020-02-19
• Study Completion: 2020-02-19
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 772

Inclusion Criteria

• Groups 1 and 2 (overweight and obese groups):
• Age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4
• Overweight or obese, as defined by a BMI ≥ 85th% & <95th% or BMI ≥ 95th%, respectively by age and sex, and for those 16 years and older, BMI ≥25 and <30 and BMI ≥30
• For Group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes
• Group 3 (Normal weight controls):
• Age 8-17 years
• Healthy weight, as defined by a BMI ≥ 5th percentile & < 85th percentile, respectively by age and sex

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Exclusion Criteria

• Previous diagnosis of type 1 diabetes
• Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
• Verbal report of Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of glucose tolerance	Up to 5 years	Normal glucose tolerance, prediabetes, or diabetes

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States