Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

Study Overview
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Brief Summary
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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.

Official Title
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Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

Conditions
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PreDiabetes, Obesity, Childhood

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Overweight or Obese Group (visits #1-4)<br>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)<br>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<br>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?
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Primary Outcome Measures

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