Trial record 12 of 30 for:    Open Studies | "Malabsorption Syndromes" | United States

Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sonia Caprio, Yale University
ClinicalTrials.gov Identifier:
NCT01967849
First received: July 15, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Obesity
Type 2 Diabetes
Procedure: Oral Glucose tolerance test
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Glucose Tolerance [ Time Frame: Baseline measurements ] [ Designated as safety issue: No ]
    Glucose tolerance status as determined by 3 hour oral glucose tolerance test


Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: Completed at baseline measurement ] [ Designated as safety issue: No ]
    Insulin secretion measured during OGTT by variety of insulin resistance calculations (WBISI, DI, IGI, HOMA-IR)


Other Outcome Measures:
  • Gene Expression [ Time Frame: Completed at baseline measurement ] [ Designated as safety issue: No ]
    Gene mutation/allelle variation identification measured via gene extraction


Estimated Enrollment: 2000
Study Start Date: September 1999
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese/overweight chldren/adolescents
Obese or overweight children and adolescents between ages 7-21 that are at risk for developing type 2 diabetes. Subjects are not eligible 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.
Procedure: Oral Glucose tolerance test
Placebo Comparator: 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. Lean is defined as a body mass index (BMI) (kg/m2) less than the 85th percentile specific for age and gender.
Procedure: Oral Glucose tolerance test

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.

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967849

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

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Sonia Caprio, MD    203-764-9199      
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Sonia Caprio, MD Yale Pediatric Endocrinology
  More Information

No publications provided

Responsible Party: Sonia Caprio, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01967849     History of Changes
Other Study ID Numbers: 11190, R01HD040787
Study First Received: July 15, 2013
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
obesity
type 2 diabetes

Additional relevant MeSH terms:
Malabsorption Syndromes
Carbohydrate Metabolism, Inborn Errors
Diabetes Mellitus, Type 2
Obesity
Overweight
Body Weight
Diabetes Mellitus
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Intestinal Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014