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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
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment Phase
Addison Disease Drug: Hydrocortisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: Hydrocortisone
Cortef 5 mg tablets per os, 2x5 mg, one day, one time
Other Name: Cortef

Primary Outcome Measures :
  1. O2 uptake [ Time Frame: 2 days ]
    O2 uptake as V O2 90%.

Secondary Outcome Measures :
  1. post- exercise hypoglycemic events [ Time Frame: 4 days ]
    blood glucose below ≤ 3.1 mmol ⁄ L

  2. glycemic variability [ Time Frame: 6 days ]
    glycemic variability monitored by continuous glucose monitoring system

  3. 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

  4. Blood pressure [ Time Frame: 2 days ]
    vascular action

  5. Subjective health status [ Time Frame: 2 days ]
    Self administration by questionnaires

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

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

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Haukeland Universitetessykehus, Department of Medicine
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
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Study Director: Eystein Husebye, Professor Haukeland University Hospital
Principal Investigator: Katerina Simunkova, MUDr. PhD Haukeland University Hospital
Additional Information:

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01847690    
Other Study ID Numbers: 2012/2216
2012-005117-40 ( EudraCT Number )
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013
Keywords provided by Haukeland University Hospital:
Addison Disease
Additional relevant MeSH terms:
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Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents