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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Oral treatment 3 times a day. Weight adjusted doses.
Haukeland University Hospital
Bergen, Norway
Karolinska Institutet
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
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
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