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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 22, 2014
Last verified: April 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 22, 2014
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 September 30, 2014