Adrenocortical Insufficiency Clinical Trial
Official title:
Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Intestinal chronic inflammatory diseases (Crohn's disease, chronic ulcerative colitis) - Systemic prolonged treatment with corticosteroids during 2 months at least - Discontinuation of the treatment with corticosteroids for 6 weeks - Basal plasma cortisol between 8 and 20 µg / dl (220 to 550 nmol / l). Exclusion Criteria: - Systemic prolonged treatment with corticosteroids because of an other disease than a intestinal chronic inflammatory disease - Pregnancy, breast feeding - Hypersensibility to synacthene - Basal plasma cortisol lower than 8 µg / dl (220 nmol / l) or superior to 20 µg / dl (550 nmol / l) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique-Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 2 years | Yes | |
| Secondary | To determine the relation between the value of basal cortisol and the peak of stimulation of cortisol during short and long tests - to determine the relation between cortisol assay in the plasma and in the saliva | 2 years | Yes |