Clinical Trial: Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

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.

Detailed Summary:

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.


Sponsor: Yale University

Current Primary Outcome: Glucose Tolerance [ Time Frame: Baseline measurements ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Insulin resistance [ Time Frame: Completed at baseline measurement ]

Insulin secretion measured during OGTT by variety of insulin resistance calculations (WBISI, DI, IGI, HOMA-IR)


Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: July 15, 2013
Date Started: September 1999
Date Completion: September 2020
Last Updated: April 25, 2017
Last Verified: April 2017