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Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

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ClinicalTrials.gov Identifier: NCT01967849
Recruitment Status : Recruiting
First Posted : October 23, 2013
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Diagnostic Test: Oral Glucose tolerance test Not Applicable

Detailed Description:

The patient participates in the study for a total duration of approximately four hours. The study nurse will do a nursing assessment, including measuring the patient's height, weight, waist circumference, hip circumference, blood pressure, and pulse, along with evaluation of acanthosis nigricans and striae rubrae. The patient's percent body fat, fat mass and lean mass may also be measured using a Tanita scale. The nurse will obtain a family and medical history from the patient and/or the patient's parent/guardian. In addition, before starting the oral glucose tolerance test (OGTT), the nurse will request a urine sample from the patient for analysis of microalbumin and creatinine.

The patient will receive 1.75 g/kg to a maximum of 75 g of a sugar drink, orally (Glucola). The patient will have one intravenous line. "Emla" or a local anesthetic (0.1cc buffered lidocaine) will be applied before the placement of the IV catheter. Blood will be drawn 10 times over three hours. Should abnormal glucose results be found, appropriate referrals will be made. We will draw approximately 80 cc of blood during this study. The blood will be analyzed for glucose, lactate, insulin, proinsulin, c-peptide, interleukin-6, tumor necrosis factor-α(TNF), free fatty acids (FFAs), enhanced lipid profile, leptin, and adiponectin as well as an optional 10 cc sample to be stored for future undetermined analysis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children
Study Start Date : September 1999
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Glucose Tolerance [ Time Frame: Baseline measurements ]
    Glucose tolerance status as determined by 3 hour oral glucose tolerance test


Secondary Outcome Measures :
  1. Insulin resistance [ Time Frame: Completed at baseline measurement ]
    Insulin secretion measured during OGTT by variety of insulin resistance calculations (WBISI, DI, IGI, HOMA-IR)


Other Outcome Measures:
  1. Gene Expression [ Time Frame: Completed at baseline measurement ]
    Gene mutation/allelle variation identification measured via gene extraction


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967849


Contacts
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Contact: Melissa M Shaw 2037856459 melissa.m.shaw@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Sonia Caprio, MD    203-764-9199      
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sonia Caprio, MD Yale Pediatric Endocrinology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01967849    
Other Study ID Numbers: 9909011190
R01HD040787 ( U.S. NIH Grant/Contract )
1R01DK111038-01A1 ( U.S. NIH Grant/Contract )
2R01HD028016-20A1 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yale University:
obesity
type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Overweight
Body Weight
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases