Effects of "in UTERO" Exposure to Glucocorticoids

NCT01367106 | Unknown

• 1 other identifier: P081209
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

21-hydroxylase; Defect

Keywords

offspring of 21-hydroxylase enzyme block

Outcome Measures

Primary Outcomes (1)

• Glucose Tolerance

  the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow

  3 days

Secondary Outcomes (3)

• Insulin Sensitivity

  3 days

• Flow measurement of insulin secretory response to intravenous glucose

  3 days

• Measurement of the secretion of insulin and glucagon in response to arginine

  3 days

Study Arms (2)

exposed offspring

EXPERIMENTAL

Procedure: Euglycemic hyperinsulinemic clamp

controls

OTHER

Procedure: Euglycemic hyperinsulinemic clamp

Interventions

Euglycemic hyperinsulinemic clamp PROCEDURE

Euglycemic hyperinsulinemic clamp will be performed at day 2

controls; exposed offspring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital saint Louis

Paris, 75010, France

Location

Professor GAUTIER

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 31665349 DERIVED

Study Officials

• Jean-François GAUTIER, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: June 6, 2011
• Study Start: November 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

FR (2)