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Effects of "in UTERO" Exposure to Glucocorticoids (GLUCODEX)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01367106
First received: May 24, 2011
Last updated: January 31, 2013
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
21-hydroxylase; Defect
 Procedure: Euglycemic hyperinsulinemic clamp

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Glucose Tolerance [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow


Secondary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Flow measurement of insulin secretory response to intravenous glucose [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Measurement of the secretion of insulin and glucagon in response to arginine [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exposed offspring Procedure: Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
Other Name: Euglycemic hyperinsulinemic clamp
controls Procedure: Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
Other Name: Euglycemic hyperinsulinemic clamp

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367106

Contacts
Contact: Jean-François GAUTIER, MD, PhD 33 (0) 42 49 96 87 jean-francois.gautier@sls.aphp.fr

Locations
France
Professor GAUTIER Recruiting
Paris, France
Principal Investigator: Jean-Francois GAUTIER, MD PhD            
Hôpital saint Louis Not yet recruiting
Paris, France, 75010
Contact: Jean-François GAUTIER, MD, PhD     33 (0)142499687     jean-francois.gautier@sls.aphp.fr    
Principal Investigator: Jean-François GAUTIER, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-François GAUTIER, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01367106     History of Changes
Other Study ID Numbers: P081209
Study First Received: May 24, 2011
Last Updated: January 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
offspring of 21-hydroxylase enzyme block

Additional relevant MeSH terms:
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013