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The etiology and extent of impaired quality of life, fatigue and cognitive, affective and emotional dysfunction in patients with Cushing*s syndrome ;- Prospective studies using structural and functional magnetic resonance imaging, positron emission tomography, genetic and cerebrospinal fluid analysis - <br>

Recruiting
Conditions
Cushing's disease
Hypercortisolism
10021112
Registration Number
NL-OMON50171
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

• Male and female patients with Cushing's syndrome caused by ACTH-producing
pituitary adenoma or cortisol producing adrenal adenoma
• Age between 18 and 65 years

Exclusion Criteria

• Cushing's syndrome caused by ectopic ACTH producing tumours
• Cushing's syndrome caused by adrenocortical carcinoma
• Pseudo Cushing
• Subclinical Cushing's syndrome
• Exogenous CS
• Previous history of major psychiatric disorder (not related to Cushing's
syndrome)
• Neurological disorders affecting the central nervous system
• High alcohol consumption (more than 14 alcohol units per week)
• Active malignancy or any treatment for malignancy during the last 2 years
• Heart failure (NYHC II-IV)
• Severe respiratory insufficiency
• Severely impaired hepatic function (ALT and/or AST concentrations two times
above the upper limit of normal)
• Severely impaired renal function (s-creatinine >150 µmol/L or GFR <45 ml/min)
• Pregnancy or breast feeding
• Any other illness that significantly affects the patients cognitive function
according to the investigators opinion
• Contraindication for MRI (Presence of medical implants, metal in the body,
claustrophobia)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary study parameters of fMRI:<br /><br>1. Total brain volume and volume of structures important for cognitive function<br /><br>2. Structural connectivity and integrity of white matter<br /><br>3. Brain functional connectivity during rest and during testing of cognitive<br /><br>and emotional functioning<br /><br><br /><br>Other primary study parameters:<br /><br>1. Genetic analysis of polymorfisms in the glucocorticoid receptor gene and<br /><br>genes involved in metabolism and transports of glucocorticoids<br /><br>2. Brain injury biomarkers<br /><br>3. Cognitive function<br /><br>4. Quality of life, fatigue scores, depression and anxiety scores, apathy<br /><br>scores</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable</p><br>
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