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Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01847690
First received: April 23, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Addison Disease
Drug: Hydrocortisone
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • O2 uptake [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    O2 uptake as V O2 90%.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847690

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

Additional Information:
Publications:

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01847690     History of Changes
Other Study ID Numbers: 2012/2216, 2012-005117-40
Study First Received: April 23, 2013
Last Updated: November 29, 2013
Health Authority: Norway: Norwegian Medicines Agency
Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Addison Disease

Additional relevant MeSH terms:
Addison Disease
Adrenal Gland Diseases
Adrenal Insufficiency
Autoimmune Diseases
Endocrine System Diseases
Immune System Diseases
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014