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Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome

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ClinicalTrials.gov Identifier: NCT03211624
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Leiden University Medical Center
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
This is a prospective, multi-center, case-control study where neurocognitive function will be evaluated in 36 patients with Cushing syndrome (CS) and 36 controls matched for age, gender and education.

Condition or disease
Cushing Syndrome

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Etiology and Extent of Impaired Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome - Prospective Studies
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023


Group/Cohort
Cushing syndrome
Male and female patients with Cushing syndrome caused by ACTH-producing pituitary adenoma or cortisol producing adrenal adenoma
Controls
Healthy controls matched for age, gender, and educational level



Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 2 years ]
    Improvement in memory 2 years after treatment of Cushing syndrome evaluated with the Rey Complex Figure.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    Improvement in quality of life 2 years after treatment of Cushing syndrome, measured with the CushingQoL

  2. Brain volume [ Time Frame: 2 years ]
    Changes in total brain volume and volume of structures important for cognitive function such as hippocampus and frontal cortex 2 years after treatment of Cushing syndrome by using structural MRI

  3. Functional brain response [ Time Frame: 2 years ]
    Changes in brain functional connectivity during rest and during testing of cognitive and emotional functioning 2 years after treatment of Cushing syndrome by using functional MRI

  4. Glucose utilization [ Time Frame: 2 years ]
    Change in glucose utilization in the hippocampus and frontal cortex 2 years after treatment of Cushing syndrome by using Fludeoxyglucose Positron emission tomography (FDG-PET).

  5. Genetic analysis. [ Time Frame: 2 years ]
    To evaluate the influence of polymorphisms in the GC receptor gene, and genes involved in metabolism and transport of GCs, on memory and attention in patients with CS.


Biospecimen Retention:   Samples With DNA

Blood samples for DNA and RNA isolation will be collected and stored at −80°C.

Polymorphism in the glucocorticoid (GC) receptor gene, and other genes involved in metabolism and transport of GCs will be analysed in all subjects at inclusion in the study.

DNA methylation and mRNA will be analyzed at inclusion and 24 months after treatment.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Thirty-six patients with newly diagnosed endogenous Cushing syndrome and 36 matched controls
Criteria

Inclusion criteria:

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

Exclusion criteria

  • CS caused by ectopic ACTH producing tumours
  • CS caused by adrenocortical carcinoma
  • Pseudo CS
  • Subclinical CS
  • Exogenous CS
  • Previous history of major psychiatric disorder (not related to CS)
  • Neurological disorders affecting the central nervous system
  • High alcohol consumption (more than 14 units of alcohol 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 (alanine transaminase and/or aspartate transaminase concentrations two times the upper limit of normal or above)
  • Severely impaired renal function (serum- creatinine >150 µmol/L or glomerular filtration rate <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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211624


Contacts
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Contact: Oskar Ragnarsson, MD, PhD 707292228 oskar.ragnarsson@medic.gu.se

Locations
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Netherlands
Dept of Medicine, Division of Endocrinology, and Center for Endocrine Tumors, Leiden University Medical Center Enrolling by invitation
Leiden, Netherlands
Spain
Dept of Endocrinology, Hospital Sant Pau Recruiting
Barcelona, Spain
Contact: Susan Webb, MD, PhD       SWebb@santpau.cat   
Sweden
Sahlgrenska University Hospital Enrolling by invitation
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Leiden University Medical Center
Investigators
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Principal Investigator: Oskar Ragnarsson, MD, PhD Sahlgrenska University Hospital, Sweden

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03211624     History of Changes
Other Study ID Numbers: CognCush
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be available for other researcher upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cushing Syndrome
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases