Effects of "in UTERO" Exposure to Glucocorticoids | NCT01367106

Studies
Effects of "in UTERO" Exposure to Glucocorticoids

NCT01367106

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Dec 21, 2017Actual

Enrollment

46Estimated

Phase

Not Applicable

Conditions

21-hydroxylase; Defect

Interventions

Euglycemic hyperinsulinemic clamp

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012Actual

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

May 24, 2011

First Submission Date that Met QC Criteria

Jun 3, 2011

First Posted Date

Jun 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2017

Last Update Posted Date

Dec 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Label	Type	Description	Intervention Names
exposed offspring	Experimental		Procedure: Euglycemic hyperinsulinemic clamp
controls	Other		Procedure: Euglycemic hyperinsulinemic clamp

Name	Type	Description	Arm Group Labels	Other Names
Euglycemic hyperinsulinemic clamp	Procedure	Euglycemic hyperinsulinemic clamp will be performed at day 2	controls exposed offspring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose Tolerance	the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow	3 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-François GAUTIER, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital saint Louis		Paris		75010	France
Professor GAUTIER

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31665349	Derived	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.