Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a physiologically high HC dose. In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Cortisol succinate; Epinephrine; Epinephryl borate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Racepinephrine

Criteria

Inclusion Criteria:

• Patients with secondary adrenal insufficiency.

• Age ≥ 18 - 75 years

• ≥ One year after tumor treatment with surgery and/or radiotherapy

• On stable concomitant medications for at least six months prior to entry of study

• Body weight 50-100 kg

Exclusion Criteria:

• Inability of legal consent

• Documented cognitive impairment

• Drug abuse/dependence

• History of / current psychiatric disorders

• Use of anti-epileptics (e.g. carbamezapine)

• Cushing Disease

• Type 1 diabetes or Type 2 diabetes with medication known to induce hypoglycemia (f.e. Sulfonylurea derivatives

• Current treatment for second malignancy

• Have a significant medical condition (e.g. hepatic, respiratory, or cardiovascular) which, in the opinion of the investigator, may interfere with the interpretation of results and safety or efficacy evaluations.

• A history of frequent hypocortisolism

• Hospitalization during study

• Work in shifts