Trial | NCT02096510  Report issue

Official Title

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    urea ...

  • Study Participants

    10
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.
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.
Study Started
Aug 31
2014
Primary Completion
Dec 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Dec 21
2016
Estimate

Drug Solu-Cortef

administration by pump for minimum 2 weeks

  • Other names: hydrocortisone

Drug Cortef

tablet treatment 2 ro 3 times per day for 14 days

  • Other names: hydrocortisone tablets

continuous subcutaneous hydrocortisone Experimental

continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate

cortef tablets Active Comparator

the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.

ultradian subcutaneous hydrocortisone Experimental

ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate

Criteria 

Inclusion Criteria:

clinical diagnosis of primary adrenal insufficiency
Written informed consent

Exclusion Criteria:.

Diabetes mellitus
Severe cardiovascular disease
Active malignant disease
Pregnancy or breast feeding
treatment with interfering drugs
Intake of grapefruit juice
No Results Posted