Yale University
New Haven, Connecticut, 06520, United States
NCT Number: NCT01967849
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.
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Notify Me7 year–21 year
All sexes
Observational
New Haven, Connecticut, 06520, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline measurements
Glucose tolerance status as determined by 3 hour oral glucose tolerance test
Time frame: Completed at baseline measurement
Insulin secretion measured during OGTT by variety of insulin resistance calculations (WBISI, DI, IGI, HOMA-IR)
Time frame: Completed at baseline measurement
Gene mutation/allelle variation identification measured via gene extraction
Yale University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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