Clinical Trial: Glucocorticoid Treatment in Addison's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Glucocorticoid Treatment in Addison's Disease

Brief Summary:

Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.

The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.


Detailed Summary:
Sponsor: Haukeland University Hospital

Current Primary Outcome: Morning (08-09) plasma ACTH [ Time Frame: Time 0, months 2, 3, 5, 7 and 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores [ Time Frame: At time 0 and months 2,3,5,7 and 8 ]
  • Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary [ Time Frame: PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7 ]
  • 24h cortisol profiles in serum and saliva [ Time Frame: months 2 and 7 ]
  • S-glucose, 24 h profile [ Time Frame: months 2 and 7 ]
  • Insulin sensitivity assessed by euglycemic clamp [ Time Frame: Months 2 and 7 ]


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: January 26, 2010
Date Started: February 2010
Date Completion:
Last Updated: March 19, 2013
Last Verified: March 2013