An intervention study of the effects of a low dose and high dose hydrocortisone replacement therapy on brain functions, quality of life, risk factors for cardiovascular diseases and sensitivity in patients with adrenal insufficiency due to a previous pituitary tumor.
- Conditions
- Secondary adrenal insufficiencyMedDRA version: 14.0Level: LLTClassification code 10020518Term: HydrocortisoneSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2011-000864-82-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 63
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency.Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks) ;Main Objective: The aim of this study is to investigate whether a physiologically low HC dose is better for cognition as compared to a high HC dose. ;Secondary Objective: In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose. ;Primary end point(s): Cognitive performance. <br>If the significance value is less than .05, there is a significant difference. This will be calculated with a paired samples t-test. <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Quality of Life (QoL),<br>Metabolic profile<br>Somatosensation<br>;Timepoint(s) of evaluation of this end point: First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency.<br>Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks)