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OpenTrials
Completed

NCT Number: NCT01063569

Glucocorticoid Treatment in Addison's Disease

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.

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Key information

Conditions

Addison's Disease Addison Disease Adrenal Gland Diseases Adrenal Insufficiency Autoimmune Diseases Endocrine System Diseases Immune System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Solu-Cortef (hydrocortisone)

Drug

Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.

Other names: Solu-Cortef

Cortef (hydrocortisone)

Drug

Oral treatment 3 times a day. Weight adjusted doses.

Other names: Cortef 5 mg

Primary outcomes

  1. Morning (08-09) plasma ACTH

    Time frame: Time 0, months 2, 3, 5, 7 and 8

Secondary outcomes

  1. 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

  2. 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

  3. 24h cortisol profiles in serum and saliva

    Time frame: months 2 and 7

  4. S-glucose, 24 h profile

    Time frame: months 2 and 7

  5. Insulin sensitivity assessed by euglycemic clamp

    Time frame: Months 2 and 7

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 5, 2010
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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