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Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome
This study is currently recruiting participants.
Verified July 2017 by Göteborg University
Sponsor:
Göteborg University
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
ClinicalTrials.gov Identifier:
NCT03211624
First received: June 14, 2017
Last updated: July 6, 2017
Last verified: July 2017
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Purpose
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 |
|---|
| Cushing Syndrome |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Göteborg University:
Primary Outcome Measures:
- 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:
- Quality of life [ Time Frame: 2 years ]Improvement in quality of life 2 years after treatment of Cushing syndrome, measured with the CushingQoL
- 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
- 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
- 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).
- 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.
| Estimated Enrollment: | 72 |
| Actual Study Start Date: | May 1, 2017 |
| Estimated Study Completion Date: | December 31, 2023 |
| Estimated Primary Completion Date: | December 31, 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211624
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211624
Contacts
| Contact: Oskar Ragnarsson, MD, PhD | 707292228 | oskar.ragnarsson@medic.gu.se |
Locations
| 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
| Principal Investigator: | Oskar Ragnarsson, MD, PhD | Sahlgrenska University Hospital, Sweden |
More Information
| Responsible Party: | Göteborg University |
| ClinicalTrials.gov Identifier: | NCT03211624 History of Changes |
| Other Study ID Numbers: |
CognCush |
| Study First Received: | June 14, 2017 |
| Last Updated: | July 6, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All data will be available for other researcher upon request. |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Syndrome Fatigue Cushing Syndrome Disease Pathologic Processes |
Signs and Symptoms Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on July 11, 2017