Glucocorticoid Treatment in Addison's Disease
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.
|Addison's Disease||Drug: Solu-Cortef (hydrocortisone) Drug: Cortef (hydrocortisone)||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Glucocorticoid Treatment in Addison's Disease|
- Morning (08-09) plasma ACTH [ Time Frame: Time 0, months 2, 3, 5, 7 and 8 ]
- 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 ]
|Study Start Date:||February 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Oral hydrocortisone||
Drug: Cortef (hydrocortisone)
Oral treatment 3 times a day. Weight adjusted doses.
Other Name: Cortef 5 mg
|Experimental: Continous subcutaneous hydrocortisone infusion||
Drug: Solu-Cortef (hydrocortisone)
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Other Name: Solu-Cortef
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063569
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Principal Investigator:||Kristian Løvås, MD,PhD||Haukeland University Hospital|