Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure
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|ClinicalTrials.gov Identifier: NCT01847690|
Recruitment Status : Unknown
Verified November 2013 by Haukeland University Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 7, 2013
Last Update Posted : December 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Addison Disease||Drug: Hydrocortisone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||March 2014|
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
- O2 uptake [ Time Frame: 2 days ]O2 uptake as V O2 90%.
- post- exercise hypoglycemic events [ Time Frame: 4 days ]blood glucose below ≤ 3.1 mmol ⁄ L
- glycemic variability [ Time Frame: 6 days ]glycemic variability monitored by continuous glucose monitoring system
- hormone response to exercise [ Time Frame: 2 days ]
- 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 ]vascular action
- Subjective health status [ Time Frame: 2 days ]Self administration by questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|