Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2012-11-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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exposed offspring
Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
controls
Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
Interventions
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Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Accepting the constraints of the protocol and had signed informed and free consent.
* Affiliated to the Social Security.
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-François GAUTIER, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital saint Louis
Paris, , France
Professor GAUTIER
Paris, , France
Countries
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References
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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.
Other Identifiers
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P081209
Identifier Type: -
Identifier Source: org_study_id