Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

PreDiabetes Clinical Trial

Official title:

Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055219
• Other study ID #: HUM00006955
• Secondary ID: 5R01HD074559-05
• Status: Completed
• Start date: June 2015
• Est. completion date: February 19, 2020

Study information

• Verified date: September 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 772
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Obesity, Childhood
• Pediatric Obesity
• PreDiabetes
• Prediabetic State

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of glucose tolerance	Normal glucose tolerance, prediabetes, or diabetes	Up to 5 years