Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

University of Michigan

Status: Completed

Conditions: Obesity, Childhood; PreDiabetes

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05055219

HUM00006955

5R01HD074559-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 772 patients

Sex: All

Ages: 8 to 22 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

772 participants in 3 patient groups

Group 1: Overweight or Obese Group (visits #1-4)

Description:

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)

Description:

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

Description:

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.