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

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ClinicalTrials.gov Identifier: NCT01367106
Recruitment Status : Active, not recruiting
First Posted : June 6, 2011
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
21-hydroxylase; Defect Procedure: 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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : November 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: exposed offspring Procedure: Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2
controls Procedure: Euglycemic hyperinsulinemic clamp
Euglycemic hyperinsulinemic clamp will be performed at day 2


Outcome Measures

Primary Outcome Measures :
  1. Glucose Tolerance [ Time Frame: 3 days ]
    the tolerance will be measured by the area under the curve (AUC) of insulin secretion flow


Secondary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 3 days ]
  2. Flow measurement of insulin secretory response to intravenous glucose [ Time Frame: 3 days ]
  3. Measurement of the secretion of insulin and glucagon in response to arginine [ Time Frame: 3 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367106


Locations
France
Hôpital saint Louis
Paris, France, 75010
Professor GAUTIER
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-François GAUTIER, MD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01367106     History of Changes
Other Study ID Numbers: P081209
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

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