Effects of "in UTERO" Exposure to Glucocorticoids

NCT ID: NCT01367106

Last Updated: 2017-12-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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

Conditions

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21-hydroxylase; Defect

Keywords

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offspring of 21-hydroxylase enzyme block

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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exposed offspring

Group Type EXPERIMENTAL

Euglycemic hyperinsulinemic clamp

Intervention Type PROCEDURE

Euglycemic hyperinsulinemic clamp will be performed at day 2

controls

Group Type OTHER

Euglycemic hyperinsulinemic clamp

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Exclusion Criteria

* Negative blood HCG
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Professor GAUTIER

Paris, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 31665349 (View on PubMed)

Other Identifiers

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P081209

Identifier Type: -

Identifier Source: org_study_id