Addison's Disease Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients with verified Addison's disease on stable treatment. Exclusion Criteria: - Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy. - Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | |
Sweden | Karolinska Institutet | Stockholm | |
Sweden | Uppsala University | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morning (08-09) plasma ACTH | Time 0, months 2, 3, 5, 7 and 8 | No | |
Secondary | Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores | At time 0 and months 2,3,5,7 and 8 | No | |
Secondary | Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary | PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7 | No | |
Secondary | 24h cortisol profiles in serum and saliva | months 2 and 7 | No | |
Secondary | S-glucose, 24 h profile | months 2 and 7 | No | |
Secondary | Insulin sensitivity assessed by euglycemic clamp | Months 2 and 7 | No |
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