Addison's Disease
Conditions
Keywords
Addison's disease, Glucocorticoid treatment, Continuous subcutaneous hydrocortisone infusion, CSHI, Quality of Life, Sleep
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.
Interventions
DRUGSolu-Cortef (hydrocortisone)
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
DRUGCortef (hydrocortisone)
Oral treatment 3 times a day. Weight adjusted doses.
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning (08-09) plasma ACTH | Time 0, months 2, 3, 5, 7 and 8 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 24h cortisol profiles in serum and saliva | months 2 and 7 |
| S-glucose, 24 h profile | months 2 and 7 |
| Insulin sensitivity assessed by euglycemic clamp | Months 2 and 7 |
Countries
Norway, Sweden
Outcome results
None listed