Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

NCT01967849 | Completed

• 4 other identifiers: 9909011190R01HD0407871R01DK111038-01A12R01HD028016-20A1
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the prevalence of impaired glucose (carbohydrate) tolerance in lean children with a family history of diabetes and in overweight/obese children with or without a family history of diabetes mellitus.

Conditions

Obesity; Type 2 Diabetes

Keywords

obesity; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Glucose Tolerance

  Glucose tolerance status as determined by 3 hour oral glucose tolerance test

  Baseline measurements

Secondary Outcomes (1)

• Insulin resistance

  Completed at baseline measurement

Other Outcomes (1)

• Gene Expression

  Completed at baseline measurement

Study Arms (2)

Obese/overweight chldren/adolescents

Obese or overweight children and adolescents between ages 7-21 that are at risk for developing type 2 diabetes will undergo an Oral Glucose Tolerance test (OGTT) to asses glucose status.

Diagnostic Test: Oral Glucose tolerance test

Lean children/adolescents

Lean children/adolescents between the ages of 7-21. This cohort should have family members that have type 2 diabetes or was the result of a gestational diabetes pregnancy. They will undergo an Oral Glucose Tolerance Test to assess glucose status.

Diagnostic Test: Oral Glucose tolerance test

Interventions

Oral Glucose tolerance test DIAGNOSTIC_TEST

Lean children/adolescents; Obese/overweight chldren/adolescents

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Primarily these patients are recruited from Yale Pediatric Endocrinology Clinic or are siblings of patients.

You may qualify if:

• ages 7-21
• family history of type 2 diabetes mellitus

You may not qualify if:

• Children will be excluded if they have previously been treated for another endocrinopathy or are on any chronic medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil.
• Lean (not overweight or obese) will be defined as a body mass index (BMI) (kg/m2) less than the 85th percentile specific for age and gender, overweight will be defined as a BMI between the 85th and 95th percentiles, and obesity will be defined as a BMI greater than the 95th percentile.
• Children will be excluded from participating in the genetic analysis if they are treated oral glucocorticoids or antirejection or chemotherapy (e.g. tacrolimus, Lasparaginase.

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (4)

• Trico D, McCollum S, Samuels S, Santoro N, Galderisi A, Groop L, Caprio S, Shabanova V. Mechanistic Insights Into the Heterogeneity of Glucose Response Classes in Youths With Obesity: A Latent Class Trajectory Approach. Diabetes Care. 2022 Aug 1;45(8):1841-1851. doi: 10.2337/dc22-0110.

  PMID: 35766976 DERIVED

• Halloun R, Galderisi A, Caprio S, Weiss R. Lack of Evidence for a Causal Role of Hyperinsulinemia in the Progression of Obesity in Children and Adolescents: A Longitudinal Study. Diabetes Care. 2022 Jun 2;45(6):1400-1407. doi: 10.2337/dc21-2210.

  PMID: 35235641 DERIVED

• Zabarsky G, Beek C, Hagman E, Pierpont B, Caprio S, Weiss R. Impact of Severe Obesity on Cardiovascular Risk Factors in Youth. J Pediatr. 2018 Jan;192:105-114. doi: 10.1016/j.jpeds.2017.09.066.

  PMID: 29246331 DERIVED

• Hershkop K, Besor O, Santoro N, Pierpont B, Caprio S, Weiss R. Adipose Insulin Resistance in Obese Adolescents Across the Spectrum of Glucose Tolerance. J Clin Endocrinol Metab. 2016 Jun;101(6):2423-31. doi: 10.1210/jc.2016-1376. Epub 2016 Apr 7.

  PMID: 27054297 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA blood sample is obtained from IV during oral glucose tolerance test.

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Sonia Caprio, MD

  Yale Pediatric Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: October 23, 2013
• Study Start: September 1, 1999
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)