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OpenTrials
Completed

NCT Number: NCT05055219

Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

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.

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Key information

Conditions

PreDiabetes Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Childhood Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Prediabetic State Signs and Symptoms

Age range

8 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression of glucose tolerance

    Time frame: Up to 5 years

    Normal glucose tolerance, prediabetes, or diabetes

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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