Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT01367106
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01367106
Study Brief:
Protocol Section:
NCT01367106