Glucocorticoid Treatment in Addison's Disease
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|ClinicalTrials.gov Identifier: NCT01063569|
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : March 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Addison's Disease||Drug: Solu-Cortef (hydrocortisone) Drug: Cortef (hydrocortisone)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glucocorticoid Treatment in Addison's Disease|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
|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
- 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 ]
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): NCT01063569
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Principal Investigator:||Kristian Løvås, MD,PhD||Haukeland University Hospital|