Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method was recently applied to treat a patient through a critical phase of puberty. This is a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is to determine the effects of CSHI on metabolic parameters (androstenedione and 17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH), cortisol, and bone markers), and to determine the required glucocorticoid doses. Secondary objectives are to determine effects on clinical status, body weight, blood pressure and other metabolic parameters, as well as on subjective health status (AddiQoL, SF36).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Cortisol succinate; Cortisone; Cortisone acetate; Epinephrine; Epinephryl borate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Racepinephrine

Criteria

Inclusion Criteria:

• verified salt-wasting CAH and simple virilizing CAH, on single prednisone, or hydrocortisone therapy.

• In case of concomitant endocrine/autoimmune diseases these should be on stable treatment during the study period.

Exclusion Criteria:

• Patients with diabetes mellitus on insulin pump treatment will not be included in this study

• cardiovascular disease, active malignant disease and pregnancy, and pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns wart).