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Exercise Capacity and Recovery in Addison's Disease

This study is not yet open for participant recruitment.
Verified August 2012 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Smans, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01657123
First received: August 1, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic nervous system, depending on the type and intensity of the stressor. Physical exercise represents a stress condition influencing many systems in the body. Given a workload of at least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal (HPA)-axis. The increased endogenous cortisol secretion results in important metabolic and cardiovascular effects to maintain cellular and organ homeostasis. Patients with Addison's disease are not able to meet the increased demand of adrenal steroids in case of physical exercise, which may result in an impaired exercise capacity and a prolonged post-exercise recovery. We hypothesize that a hydrocortisone stress dose increases exercise capacity and improves post-exercise recovery in patients with Addison's disease.


Condition Intervention
Addison's Disease
 Other: ergometry

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • exercise capacity [ Time Frame: 140 minutes ] [ Designated as safety issue: No ]
    power in Watt and duration in minutes


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Other: ergometry
ergometry measurements
Experimental: hydrocortisone stress dosage Other: ergometry
Ergometry measurements

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Addison's disease
  • 18-50 years
  • stable glucocortiocid replacement therapy

Exclusion Criteria:

  • Presence of intercurrent (acute) infectious disease
  • Mental impairment (major depressive, anxiety, panic, adjustment, bipolar, psychotic, posttraumatic or borderline personality disorder)
  • Presence of the following chronic diseases: diabetes mellitus, chronic obstructive pulmonary disease, renal failure, chronic anaemia, malignancy, rheumatoid arthritis
  • Presence of the following cardiovascular conditions: unstable angina pectoris, history of myocardial infarction, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic (severe) aortic stenosis, uncontrolled symptomatic heart failure, acute myocarditis or pericarditis, left main coronary stenosis, moderate stenotic valvular heart disease, tachyarrhythmias or bradyarrhythmias, hypertrophic cardiomyopathy and other forms of outflow tract obstruction, high-degree atrioventricular block
  • History of pulmonary embolus or pulmonary infarction
  • Known aortic aneurysm
  • Severe hypertension (>170/100 mm Hg)
  • Medication that affects cardiovascular function (beta-blocker, calcium antagonist, ACE-inhibitors, aldosterone-antagonists)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657123

Contacts
Contact: Lisanne Smans, drs 0031616796646 l.c.c.j.smans@umcutrecht.nl
Contact: Pierre Zelissen, dr 0031887550686 p.m.j.zelissen@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Lisanne Smans, drs     0031616796646     l.c.c.j.smans@umcutrecht.nl    
Contact: Pierre Zelissen, dr     0031887550686     p.m.j.zelissen@umcutrecht.nl    
Sponsors and Collaborators
UMC Utrecht
  More Information

No publications provided

Responsible Party: Smans, drs, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01657123     History of Changes
Other Study ID Numbers: 33088
Study First Received: August 1, 2012
Last Updated: August 2, 2012
Health Authority: The Netherlands: Julius Clinical Research

Keywords provided by UMC Utrecht:
exercise capacity
Addison's disease

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

ClinicalTrials.gov processed this record on May 23, 2013