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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes; Obesity, Childhood

• Study Type: Observational
• Enrollment (Actual): 772

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of normal weight, overweight or obese individuals aged 8 to 17 years at visits #1 and #2, and can be as old as 22 years for follow-up visits #3 and #4. Participants will be recruited from a variety of sites including University Michigan clinical sites, non-University of Michigan clinical sites, schools in the local area, and the University Michigan medical school campus. Participants from Group 2 (visits #3-4) completed visits #1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1: Overweight or Obese Group (visits #1-4); Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight. Overweight or obese, as defined by a BMI ≥ 85th percentile & <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin.
Group 2: Overweight or Obese Group (visits #3-4); Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight, or children and young adults who previously participated in the study (completed visits #1-2 in previous study phase). Overweight or obese, as defined by a BMI ≥ 85th percentile & <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin.
Group 3: Normal Weight Control Group; Children and adolescents who are 8 to 17 years of age, who have do not have risk factors for diabetes such as being overweight or a history of type 2 diabetes in the family. Healthy weight, as defined by a BMI ≥ 5th percentile & < 85th percentile. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of glucose tolerance	Normal glucose tolerance, prediabetes, or diabetes	Up to 5 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Joyce Lee, MD, MPH, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Hyperglycemia; Obesity; Pediatric Obesity; Prediabetic State; Glucose Intolerance; Insulin Resistance
• Other Study ID Numbers: HUM00006955; 5R01HD074559-05 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No