Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT01847690 |
Date of registration:
|
23/04/2013 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure
|
Scientific title:
|
Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal |
Date of first enrolment:
|
June 2013 |
Target sample size:
|
20 |
Recruitment status: |
Active, not recruiting |
URL:
|
http://clinicaltrials.gov/show/NCT01847690 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
Norway
| | | | | | | |
Contacts
|
Name:
|
Katerina Simunkova, MUDr. PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Haukeland University Hospital |
|
Name:
|
Eystein Husebye, Professor |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Haukeland University Hospital |
| |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- patients with Addison`s disease
Exclusion Criteria:
- Type 1 diabetes
- malignant disease
- pregnant women
- cardiac disease
- lung disease
- neuromuscular diseases
- pharmacological treatment with glucocorticoids or drugs that interfere with cortisol
metabolism (anti-epileptics, rifampicin, St Johns wart, oral estrogens,
antidepressives).
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
|
Health Condition(s) or Problem(s) studied
|
Addison Disease
|
Intervention(s)
|
Drug: Hydrocortisone
|
Primary Outcome(s)
|
O2 uptake
[Time Frame: 2 days]
|
Secondary Outcome(s)
|
hormone response to exercise
[Time Frame: 2 days]
|
Blood pressure
[Time Frame: 2 days]
|
glycemic variability
[Time Frame: 6 days]
|
post- exercise hypoglycemic events
[Time Frame: 4 days]
|
Subjective health status
[Time Frame: 2 days]
|
Secondary ID(s)
|
2012-005117-40
|
2012/2216
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|