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 -

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 - - The etiology of impaired QoL and cognitive dysfunction in patients with CS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50171

Enrollment

Registered

2020-12-29

Start date

2018-10-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing's disease Hypercortisolism

Interventions

Affective and emotional dysfunction

Cognitive impairment

Cushing's syndrome

Quality of life

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary study parameters of fMRI: 1. Total brain volume and volume of structures important for cognitive function 2. Structural connectivity and integrity of white matter 3. Brain functional connectivity during rest and during testing of cognitive and emotional functioning Other primary study parameters: 1. Genetic analysis of polymorfisms in the glucocorticoid receptor gene and genes involved in metabolism and transports of glucocorticoids 2. Brain injury biomarkers 3. Cognitive function 4. Quality of life, fatigue scores, depression and anxiety scores, apathy scores	—

Measure

Time frame

Primary study parameters of fMRI: 1. Total brain volume and volume of structures important for cognitive function 2. Structural connectivity and integrity of white matter 3. Brain functional connectivity during rest and during testing of cognitive and emotional functioning Other primary study parameters: 1. Genetic analysis of polymorfisms in the glucocorticoid receptor gene and genes involved in metabolism and transports of glucocorticoids 2. Brain injury biomarkers 3. Cognitive function 4. Quality of life, fatigue scores, depression and anxiety scores, apathy scores

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)