Glucocorticoid Treatment in Addison's Disease
Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Addison's Disease
Intervention: Solu-Cortef (hydrocortisone) (Drug); Cortef (hydrocortisone) (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Haukeland University Hospital Official(s) and/or principal investigator(s): Kristian Løvås, MD,PhD, Principal Investigator, Affiliation: Haukeland University Hospital
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.
Clinical Details
Official title: Glucocorticoid Treatment in Addison's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Morning (08-09) plasma ACTH
Secondary outcome: Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scoresSleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary 24h cortisol profiles in serum and saliva S-glucose, 24 h profile Insulin sensitivity assessed by euglycemic clamp
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Haukeland University Hospital, Bergen 5021, Norway
Karolinska Institutet, Stockholm, Sweden
Uppsala University, Uppsala, Sweden
Additional Information
Starting date: February 2010
Last updated: March 19, 2013
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