Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children
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- STATUS
- Recruiting
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- End date
- Sep 8, 2025
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- participants needed
- 2000
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- sponsor
- Yale University
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.
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-(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.
Details
| Condition | diabetes type 2, type 2 diabetes mellitus, noninsulin-dependent diabetes mellitus, Diabetes Mellitus Types I and II, type 2 diabetes, Diabetes Prevention, Diabetes (Pediatric), Diabetes Mellitus, Type 2, NIDDM, Diabetes Mellitus, adiposity, Diabetes Mellitus Type 2, type ii diabetes, Obesity |
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| Treatment | Oral glucose tolerance test |
| Clinical Study Identifier | NCT01967849 |
| Sponsor | Yale University |
| Last Modified on | 7 October 2022 |
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