Clinical trial NCT01367106: Effects of "in UTERO" Exposure to Glucocorticoids
Official title: Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 21-hydroxylase; Defect
Keywords: offspring of 21-hydroxylase enzyme block
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Glucose Tolerance
timeFrame: 3 days
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: 3 days
measure: Flow measurement of insulin secretory response to intravenous glucose
timeFrame: 3 days
measure: Measurement of the secretion of insulin and glucagon in response to arginine
timeFrame: 3 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital saint Louis
city: Paris
country: France
facility: Professor GAUTIER
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-François GAUTIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riveline JP, Baz B, Nguewa JL, Vidal-Trecan T, Ibrahim F, Boudou P, Vicaut E, Brac de la Perriere A, Fetita S, Breant B, Blondeau B, Tardy-Guidollet V, Morel Y, Gautier JF. Exposure to Glucocorticoids in the First Part of Fetal Life is Associated with Insulin Secretory Defect in Adult Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz145. doi: 10.1210/clinem/dgz145.