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

Primary Purpose

Adrenocortical Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"long" synacthen stimulation test
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenocortical Insufficiency focused on measuring adrenocortical insufficiency, prolonged corticotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Assistance Publique-Hopitaux de Marseille

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2010
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01053754
Brief Title
Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids
Official Title
Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

5. Study Description

Brief 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.
Detailed Description
Synthetic glucocorticoids (GC) are used in the treatment of numerous inflammatory or auto-immune diseases, in particular the intestinal chronic inflammatory diseases (Crohn's disease, chronic ulcerative colitis). In case of discontinuation of a prolonged (superior to 3-4 weeks) and systemic treatment, deleterious side effects are frequent, with in particular a risk of adrenocortical insufficiency and withdrawal cortisonic syndrome. Our protocol of medical research concerns these two complications, and aims at optimizing the evaluation of the adrenal function. The adrenocortical insufficiency after prolonged corticotherapy is the most frequent cause of secondary adrenocortical insufficiency. It is due to the braking of the hypothalamo-pituitary-adrenal (HPA) axis which controls the endogenous secretion of cortisol. It is mostly transient, but can last several months, and exposes to a risk of acute decompensation. An adapted coverage with replacement doses of hydrocortisone (natural GC) is thus necessary during the treatment discontinuation, together with regular hormonal revaluations to track down the recovery of the adrenal function. These evaluations are based on biological measurements, because of the absence of specific clinical symptoms. At first, basal plasma cortisol at 08:00 am (physiological peak of the hormone) is assayed. A value lower than 8 µg / dl (220 nmol / l) allows to do the positive diagnosis of adrenal insufficiency and a value superior to 20 µg / dl (550 nmol / l) to exclude it. Between these 2 values, a doubt remains on the capacities of the adrenal glands to secrete enough cortisol in case of stress, and the realization of a dynamic test of stimulation is then necessary. The standard test used in common practice is the "short" synacthene stimulation test (fragment 1-24 of the ACTH, the hormone secreted by the pituitary gland and stimulating the secretion of cortisol) using an IV injection of 250 µg of immediate synacthen. 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 (classically used) and in the saliva ( which is validated for the evaluation of the other adrenal pathology as the Cushing's syndrome, but not still in the adrenocortical insufficiency after prolonged corticotherapy). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Insufficiency
Keywords
adrenocortical insufficiency, prolonged corticotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
"long" synacthen stimulation test
Intervention Description
IM injection of 1 mg of delate synacthen which can be realized in ambulatory conditions
Primary Outcome Measure Information:
Title
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine BOULLU
Organizational Affiliation
Assistance Publique-Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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

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