Overview

This trial is active, not recruiting.

Condition 21-hydroxylase; defect
Treatment euglycemic hyperinsulinemic clamp
Sponsor Assistance Publique - Hôpitaux de Paris
Start date November 2012
End date June 2016
Trial size 46 participants
Trial identifier NCT01367106, P081209

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
(Other)
euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2

Primary Outcomes

Measure
Glucose Tolerance
time frame: 3 days

Secondary Outcomes

Measure
Insulin Sensitivity
time frame: 3 days
Flow measurement of insulin secretory response to intravenous glucose
time frame: 3 days
Measurement of the secretion of insulin and glucagon in response to arginine
time frame: 3 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)
Principal investigator Jean-François GAUTIER, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.