A randomized double blind cross-over trial 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
Phase 4
Completed
- Conditions
- adrenal insufficiencysecondary adrenal insufficiency10021112
- Registration Number
- NL-OMON38411
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 63
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 psychiatric disorders
Use of anti-epileptics (e.g. carbamezapine)
Cushings disease
Type 1 or Type 2 diabetes
Current treatment for second malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is cognitive performance. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are quality of life, metabolic profile and<br /><br>somatosensation.</p><br>