Effects of "in UTERO" Exposure to Glucocorticoids
Not Applicable
- Conditions
- 21-hydroxylase; Defect
- Interventions
- Procedure: Euglycemic hyperinsulinemic clamp
- Registration Number
- NCT01367106
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- Over 18 years Aged
- Males
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exposed offspring Euglycemic hyperinsulinemic clamp - controls Euglycemic hyperinsulinemic clamp -
- Primary Outcome Measures
Name Time Method Glucose Tolerance 3 days the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Professor GAUTIER
🇫🇷Paris, France
Hôpital saint Louis
🇫🇷Paris, France