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Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children

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Врската е зачувана во таблата со исечоци
СтатусРегрутирање
Спонзори
Yale University
Соработници
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)

Клучни зборови

Апстракт

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.

Опис

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.

Датуми

Последен пат проверено: 07/31/2020
Прво доставено: 07/14/2013
Поднесено е проценето запишување: 10/16/2013
Прво објавено: 10/22/2013
Последното ажурирање е доставено: 08/10/2020
Последно ажурирање објавено: 08/11/2020
Крај на датумот на започнување на студијата: 08/31/1999
Проценет датум на примарно завршување: 08/31/2025
Проценет датум на завршување на студијата: 08/31/2025

Состојба или болест

Obesity
Type 2 Diabetes

Интервенција / третман

Diagnostic Test: Oral Glucose tolerance test

Фаза

-

Групи за раце

РакаИнтервенција / третман
Other: 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.
Other: 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.

Критериуми за подобност

Возраст подобни за студии 7 Years До 7 Years
Полови квалификувани за студииAll
Прифаќа здрави волонтериДа
Критериуми

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.

Исход

Мерки на примарниот исход

1. Glucose Tolerance [Baseline measurements]

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

Секундарни мерки на исходот

1. Insulin resistance [Completed at baseline measurement]

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

Други мерки на исход

1. Gene Expression [Completed at baseline measurement]

Gene mutation/allelle variation identification measured via gene extraction

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