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Status unknownNCT01367106GLUCODEXUpdated Dec 21, 2017

Effects of "in UTERO" Exposure to Glucocorticoids

An interventional study of Euglycemic hyperinsulinemic clamp in 21-hydroxylase; Defect, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-21.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 21-hydroxylase; Defect

Keywords

  • offspring of 21-hydroxylase enzyme block
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    exposed offspring

    Procedure: Euglycemic hyperinsulinemic clamp

  • Other
    controls

    Procedure: Euglycemic hyperinsulinemic clamp

Interventions

  • ProcedureEuglycemic hyperinsulinemic clamp

    Euglycemic hyperinsulinemic clamp will be performed at day 2

06

What researchers measure

Primary outcomes

  1. Glucose Tolerance

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

    Time frame: 3 days

Secondary outcomes

  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

07

Study locations

2 sites
  • Hôpital saint Louis
    Paris, 75010, France
  • Professor GAUTIER
    Paris, France
08

References and documents

Publications

  • 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. PubMed 31665349 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01367106
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 6, 2011
Start date
Nov 2012
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Dec 21, 2017

Study contacts

Jean-François GAUTIER, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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