Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedDecember 2, 2013
November 1, 2013
7 months
April 23, 2013
November 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
O2 uptake
O2 uptake as V O2 90%.
2 days
Secondary Outcomes (5)
post- exercise hypoglycemic events
4 days
glycemic variability
6 days
hormone response to exercise
2 days
Blood pressure
2 days
Subjective health status
2 days
Study Arms (2)
Placebo
PLACEBO COMPARATORTreatment B is placebo (2 placebo tablets).
Hydrocortisone
ACTIVE COMPARATORTreatment 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.
Interventions
Cortef 5 mg tablets per os, 2x5 mg, one day, one time
Eligibility Criteria
You may qualify if:
- patients with Addison's disease
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haukeland Universitetessykehus, Department of Medicine
Bergen, Norway, 5021, Norway
Related Publications (8)
Neary N, Nieman L. Adrenal insufficiency: etiology, diagnosis and treatment. Curr Opin Endocrinol Diabetes Obes. 2010 Jun;17(3):217-23. doi: 10.1097/MED.0b013e328338f608.
PMID: 20375886BACKGROUNDWeise M, Drinkard B, Mehlinger SL, Holzer SM, Eisenhofer G, Charmandari E, Chrousos GP, Merke DP. Stress dose of hydrocortisone is not beneficial in patients with classic congenital adrenal hyperplasia undergoing short-term, high-intensity exercise. J Clin Endocrinol Metab. 2004 Aug;89(8):3679-84. doi: 10.1210/jc.2003-032051.
PMID: 15292287BACKGROUNDWurtman RJ, Axelrod J. Control of enzymatic synthesis of adrenaline in the adrenal medulla by adrenal cortical steroids. J Biol Chem. 1966 May 25;241(10):2301-5. No abstract available.
PMID: 4287854BACKGROUNDEhrhart-Bornstein M, Bornstein SR. Cross-talk between adrenal medulla and adrenal cortex in stress. Ann N Y Acad Sci. 2008 Dec;1148:112-7. doi: 10.1196/annals.1410.053.
PMID: 19120098BACKGROUNDBornstein SR, Breidert M, Ehrhart-Bornstein M, Kloos B, Scherbaum WA. Plasma catecholamines in patients with Addison's disease. Clin Endocrinol (Oxf). 1995 Feb;42(2):215-8. doi: 10.1111/j.1365-2265.1995.tb01866.x.
PMID: 7704967BACKGROUNDGreen-Golan L, Yates C, Drinkard B, VanRyzin C, Eisenhofer G, Weise M, Merke DP. Patients with classic congenital adrenal hyperplasia have decreased epinephrine reserve and defective glycemic control during prolonged moderate-intensity exercise. J Clin Endocrinol Metab. 2007 Aug;92(8):3019-24. doi: 10.1210/jc.2007-0493. Epub 2007 May 29.
PMID: 17535996BACKGROUNDWeise M, Mehlinger SL, Drinkard B, Rawson E, Charmandari E, Hiroi M, Eisenhofer G, Yanovski JA, Chrousos GP, Merke DP. Patients with classic congenital adrenal hyperplasia have decreased epinephrine reserve and defective glucose elevation in response to high-intensity exercise. J Clin Endocrinol Metab. 2004 Feb;89(2):591-7. doi: 10.1210/jc.2003-030634.
PMID: 14764767BACKGROUNDMerke DP, Chrousos GP, Eisenhofer G, Weise M, Keil MF, Rogol AD, Van Wyk JJ, Bornstein SR. Adrenomedullary dysplasia and hypofunction in patients with classic 21-hydroxylase deficiency. N Engl J Med. 2000 Nov 9;343(19):1362-8. doi: 10.1056/NEJM200011093431903.
PMID: 11070100BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eystein Husebye, Professor
Haukeland University Hospital
- PRINCIPAL INVESTIGATOR
Katerina Simunkova, MUDr. PhD
Haukeland University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
May 7, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Study Completion
March 1, 2014
Last Updated
December 2, 2013
Record last verified: 2013-11