Clinical Trial: Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

Brief Summary: The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

Detailed Summary:

The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) and congenital adrenal hyperplasia renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach does not enable to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of glucocorticoids leads to abnormal gene transcription and causes sides effect of glucocorticoids treatment and long standing complications Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, which can mimic not only the normal diurnal cortisol rhythm, but potentially also the ultradian cadence.

This is a pilot trial with an open cross-over design of 3 x minimum 2 weeks in 10 patients comparing the effects of tablet treatment versus continuous subcutaneous hydrocortisone infusion versus ultradian subcutaneous hydrocortisone infusion on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.


Sponsor: Haukeland University Hospital

Current Primary Outcome: Serum cortisol -24 hours curve [ Time Frame: 24 hours ]

admission to hospital for 24 hours


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Salivary cortisol - 24 hours curve [ Time Frame: 24 hours ]
    admission to the hospital for 25 hours
  • 24 h urine cortisol and metabolites [ Time Frame: 24 hours ]
    urine samples for 24 hours
  • levels of corticotropic hormone [ Time Frame: 24 hours ]
    blood samples
  • 24 hours curve of tissue cortisol [ Time Frame: 24 hours ]
    The tissue effect of glucocorticoid replacement - 24 hours curve of tissue cortisol (microdialysis)
  • gene expression [ Time Frame: 24 hours ]
    m RNA expression of genes


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: November 28, 2013
Date Started: August 2014
Date Completion: December 2017
Last Updated: December 20, 2016
Last Verified: December 2016