Glucocorticoid Treatment in Addison's Disease
2 other identifiers
interventional
33
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2010
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 20, 2013
March 1, 2013
2.8 years
January 26, 2010
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morning (08-09) plasma ACTH
Time 0, months 2, 3, 5, 7 and 8
Secondary Outcomes (5)
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
Study Arms (2)
Oral hydrocortisone
ACTIVE COMPARATORContinous subcutaneous hydrocortisone infusion
EXPERIMENTALInterventions
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Oral treatment 3 times a day. Weight adjusted doses.
Eligibility Criteria
You may qualify if:
- Patients with verified Addison's disease on stable treatment.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Haukeland University Hospital
Bergen, 5021, Norway
Karolinska Institutet
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristian Løvås, MD,PhD
Haukeland University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
February 5, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
March 20, 2013
Record last verified: 2013-03