NCT01367106Unknown不适用
Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Glucose Tolerance
研究概览
简要总结
The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult.
详细描述
The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult 23 subjects of exposed offspring will be compared to 23 controls
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years Aged
- •Women of childbearing age with a reliable and effective contraception for over 2 months
- •Taking dexamethasone between the 6th and the 24th week of gestation by the mother with bloc 21-hydroxylase or normal pregnancy for control subjects
- •Normal blood pressure and heart rate measured at rest: systolic blood pressure <= 150 mmHg, diastolic blood pressure <= 90 mmHg, heart rate between 55 and 90 beats/mn.
- •Normal laboratory tests or not clinically significant abnormality NFS, platelets PT, aPTT, fibrin TP, TCA, Serum electrolytes, urea, creatinine Uric acid Triglycerides, total cholesterol, HDL cholesterol
- •Fating bood glucose <= 6.9 mmol/l (exclusion criteria for diabetes from the American Diabetes Association) during the OGTT.
- •Negative blood HCG
- •Accepting the constraints of the protocol and had signed informed and free consent.
- •Affiliated to the Social Security.
排除标准
- •Affected offspring of 21-hydroxylase enzyme block
- •Taking dexamethasone until pregnancy term by the mother of the subject
- •Type 2 diabetes in one of the two parents and/or 1 of the 4 grandparents
- •Pregnancy, Breastfeeding
- •Body Mass Index (weight/height2)> 50 kg/m2
- •Poisoning smoking (>10 cigarettes per day, whatever the duration of intoxication)
- •Any drug taken apart from minor analgesics (aspirin, paracetamol) for less than 8 days at the inclusion and oral contraception
- •Taking recent (less than 3 months) glucocorticoids either taken orally, by inhalation or percutaneously
- •Current infections or recent infections (<10 days)
- •Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
- •Having donated blood or participated in a trial within 2 months preceding their inclusion
结局指标
主要结局
Glucose Tolerance
时间窗: 3 days
the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow
次要结局
- Insulin Sensitivity(3 days)
- Measurement of the secretion of insulin and glucagon in response to arginine(3 days)
- Flow measurement of insulin secretory response to intravenous glucose(3 days)
研究者
研究点 (3)
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