Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01053754
Status:
TERMINATED
Last Update Posted:
2014-08-29
First Post:
2010-01-18
Brief Title:
Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Crohns 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 0800 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 Cushings 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
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 0800 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 Cushings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-015730-30 | None | None | None |