Glucocorticoid Treatment in Addison's Disease
Primary Purpose
Addison's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Solu-Cortef (hydrocortisone)
Cortef (hydrocortisone)
Sponsored by
About this trial
This is an interventional treatment trial for Addison's Disease focused on measuring Addison's disease, Glucocorticoid treatment, Continuous subcutaneous hydrocortisone infusion, CSHI, Quality of Life, Sleep
Eligibility 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).
Sites / Locations
- Haukeland University Hospital
- Karolinska Institutet
- Uppsala University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oral hydrocortisone
Continous subcutaneous hydrocortisone infusion
Arm Description
Outcomes
Primary Outcome Measures
Morning (08-09) plasma ACTH
Secondary Outcome Measures
Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores
Sleep; 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
Full Information
NCT ID
NCT01063569
First Posted
January 26, 2010
Last Updated
March 19, 2013
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01063569
Brief Title
Glucocorticoid Treatment in Addison's Disease
Official Title
Glucocorticoid Treatment in Addison's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addison's Disease
Keywords
Addison's disease, Glucocorticoid treatment, Continuous subcutaneous hydrocortisone infusion, CSHI, Quality of Life, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral hydrocortisone
Arm Type
Active Comparator
Arm Title
Continous subcutaneous hydrocortisone infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Solu-Cortef (hydrocortisone)
Other Intervention Name(s)
Solu-Cortef
Intervention Description
Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.
Intervention Type
Drug
Intervention Name(s)
Cortef (hydrocortisone)
Other Intervention Name(s)
Cortef 5 mg
Intervention Description
Oral treatment 3 times a day. Weight adjusted doses.
Primary Outcome Measure Information:
Title
Morning (08-09) plasma ACTH
Time Frame
Time 0, months 2, 3, 5, 7 and 8
Secondary Outcome Measure Information:
Title
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
Title
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
Title
24h cortisol profiles in serum and saliva
Time Frame
months 2 and 7
Title
S-glucose, 24 h profile
Time Frame
months 2 and 7
Title
Insulin sensitivity assessed by euglycemic clamp
Time Frame
Months 2 and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Løvås, MD,PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
Facility Name
Uppsala University
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
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Glucocorticoid Treatment in Addison's Disease
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