A randomized double blind cross-over study of the effects of low dose and high dose hydrocortisone replacement therapy on cognition, quality of life, metabolic profile and somatosensation in patients with secondary adrenal insufficiency - Hydrocortisone replacement in patients with secondary adrenal insufficiency

niversity Medical Center Groningen0 个研究点目标入组 63 人开始时间: 2011年11月23日最近更新: 2022年4月19日

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•Patients with secondary adrenal insufficiency without prior evidence of hormonal overproduction (e.g. acromegaly, Cushing disease and prolactinoma).
•Age = 18 – 70 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 33
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•Inability of legal consent
•Documented cognitive impairment
•Drug abuse/dependence
•History of or current psychiatric disorders
•Drugs that interact with hydrocortisone Use of anti-epileptics (e.g. carbamezapine)
•Premenopausal women (because of effects of estrogens on cortisol binding globulin and because differences in HPA axis functioning in the luteal or follicular phase)
•Type 1 or Type 2 diabetes
•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

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