Glucocorticoid Treatment in Addison's Disease

Phase 2

Completed

• Conditions: Addison's Disease
• Interventions: Drug: Cortef (hydrocortisone); Drug: Solu-Cortef (hydrocortisone)

• Registration Number: NCT01063569
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study Start: 2010-02
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral hydrocortisone	Cortef (hydrocortisone)	-
Continous subcutaneous hydrocortisone infusion	Solu-Cortef (hydrocortisone)	-

Primary Outcome Measures

Name	Time	Method
Morning (08-09) plasma ACTH	Time 0, months 2, 3, 5, 7 and 8

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Uppsala University; 🇸🇪 Uppsala, Sweden