Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure
The conventional glucocorticoid replacement therapy in primary adrenal insufficiency- Addison's disease,renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Many patients take stress-doses that are extra doses of hydrocortisone or cortisone acetate before or during stressful physical or psychological events. However, the effect of such dosing has not been tested in scientific studies. In this double blind cross-over designed pilot trial we aim to test the effect of an extra dose of cortisol on physical activity and hormone levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal|
- O2 uptake [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]O2 uptake as V O2 90%.
- post- exercise hypoglycemic events [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]blood glucose below ≤ 3.1 mmol ⁄ L
- glycemic variability [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]glycemic variability monitored by continuous glucose monitoring system
- hormone response to exercise [ Time Frame: 2 days ] [ Designated as safety issue: No ]
- Plasma norepinephrine, epinephrine, salivary alfa amylase
- Glucose, insulin, C-peptide, and lactate, glucagon
- Growth hormone and insulin like growth factor
- Free fatty acids
- Blood pressure [ Time Frame: 2 days ] [ Designated as safety issue: No ]vascular action
- Subjective health status [ Time Frame: 2 days ] [ Designated as safety issue: No ]Self administration by questionnaires
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Treatment B is placebo (2 placebo tablets).
Active Comparator: Hydrocortisone
Treatment A is 10 mg hydrocortisone (2 tablets Cortef, 5 mg each),Stress-dose will be taken per os one time 2 tablets 10 mg of Cortef 60 min before start of exercise. Cortef tablets 5 mg produced by Pharmacia and Upjohn . One day.
Cortef 5 mg tablets per os, 2x5 mg, one day, one time
Other Name: Cortef
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01847690
|Haukeland Universitetessykehus, Department of Medicine|
|Bergen, Norway, 5021|
|Study Director:||Eystein Husebye, Professor||Haukeland University Hospital|
|Principal Investigator:||Katerina Simunkova, MUDr. PhD||Haukeland University Hospital|