21-hydroxylase; Defect Clinical Trial
— GLUCODEXOfficial title:
Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)
| Verified date | December 2017 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 46 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital saint Louis | Paris | |
| France | Professor GAUTIER | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose Tolerance | the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow | 3 days | |
| Secondary | Insulin Sensitivity | 3 days | ||
| Secondary | Flow measurement of insulin secretory response to intravenous glucose | 3 days | ||
| Secondary | Measurement of the secretion of insulin and glucagon in response to arginine | 3 days |