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Trial record 8 of 22 for:    "Addison Disease" [DISEASE]

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Haukeland University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847690
First Posted: May 7, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
    O2 uptake as V O2 90%.


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
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


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 ( EudraCT Number )
First Submitted: April 23, 2013
First Posted: May 7, 2013
Last Update Posted: October 12, 2017
Last Verified: November 2013

Keywords provided by Haukeland University Hospital:
Addison Disease

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