Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

NCT05055219 | Completed

• 2 other identifiers: HUM000069555R01HD074559-05
• Study Type: observational
• Target: 772
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Progression of glucose tolerance

  Normal glucose tolerance, prediabetes, or diabetes

  Up to 5 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 8 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Previous diagnosis of type 1 diabetes
• Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
• Verbal report of Pregnancy

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prediabetic State; Pediatric Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joyce Lee, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: June 1, 2015
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

US (1)