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Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05055219
Enrollment
772
Registered
2021-09-24
Start date
2015-06-30
Completion date
2020-02-19
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood, PreDiabetes

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.

Interventions

None listed

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 22 Years
Healthy volunteers
Yes

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

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

Design outcomes

Primary

MeasureTime frameDescription
Progression of glucose toleranceUp to 5 yearsNormal glucose tolerance, prediabetes, or diabetes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026