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Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids

NCT01053754 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-08-29

No results posted yet for this study

Summary

The study (forward-looking and opened) will concern 70 subjects having had a systemic prolonged treatment with corticosteroids for intestinal chronic inflammatory disease, recruited in the services of gastroenterology and endocrinology of the North Hospital of Marseille (France). The primary objective of the study is to estimate a new test, the "long" synacthen stimulation test, using an IM injection of 1 mg of delate synacthen, with regard to the definitive standard. Indeed, this long test could be realized in ambulatory conditions, and turn out more contributory than the definitive standard to estimate the capacities of answer of the adrenal glands in front of a prolonged stress, as it is the case during a surgical procedure for example.

The secondary objectives are: 1) to determine the relation between the value of basal cortisol and the peak of stimulation of cortisol during short and long tests. This could allow to clarify better the conditions in which it is absolutely necessary to realize a dynamic test, 2) to determine the relation between cortisol assay in the plasma and in the saliva. The sample of saliva is simple and non-invasive, and presents the advantage to be able to be realized in ambulatory conditions and by the patient himself.

The cortisonic withdrawal syndrome is another complication which can arise when a prolonged corticosteroid therapy is discontinued. Clinically, it looks like a chronic adrenocortical insufficiency, but with normal ranges of plasma cortisol. It is probably in touch with a physical dependence to the taking of above physiological doses of GC over a long period. Its physiopathology remains badly known, but could bring in a deficit of secretion of DHEA-S (dehydro-epiandrosterone sulphate), another hormone secreted by the adrenal glands. One of the secondary objectives of the study will consist in informing the variations of DHEA-S after a prolonged corticotherapy, in the basal state and after stimulation by the long synacthen stimulation test.

Conditions

  • Adrenocortical Insufficiency

Interventions

BIOLOGICAL

"long" synacthen stimulation test

IM injection of 1 mg of delate synacthen which can be realized in ambulatory conditions

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Sandrine BOULLU · Assistance Publique-Hôpitaux de Marseille

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053754 on ClinicalTrials.gov