Effects of "in UTERO" Exposure to Glucocorticoids (GLUCODEX)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: 21-hydroxylase; Defect

Treatments: Procedure: Euglycemic hyperinsulinemic clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT01367106

P081209

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

exposed offspring

Experimental group

Treatment:

Procedure: Euglycemic hyperinsulinemic clamp

controls

Other group

Treatment:

Procedure: Euglycemic hyperinsulinemic clamp