Study Results
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Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-01-01
2021-06-23
Brief Summary
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Zinc is an important metal for brain function, with deficiency associated with poorer cognitive outcomes. In relation to POCD, biomarker studies have revealed that levels of a zinc-alpha-2-glycoprotein (AZGP1) were lower in patients with POCD. AZGP1 is a multifunctional glycoprotein implicated in cell adhesion, immune response, transmembrane transport and cellular proliferation. Microglia, the immune cells of the brain, are highly sensitive to changes in zinc which have been proposed to contribute to neurodegenerative disease as well as POCD. However, whilst animal studies looking at the effects of zinc on cognition have been promising, robust human trials are lacking.
This research aims to establish the role of zinc in POCD by determining associations between zinc status, inflammation, cognitive function, and biomarkers of POCD risk and incidence. This will be achieved by gathering clinical and cognitive data from a sample of older adults undergoing surgery. Blood samples will be taken pre and post-operatively to establish zinc status and plasma concentrations of biomarkers of POCD risk and incidence. Pre and post-operative cognitive assessments will also be conducted to measure memory and executive function. Incidence of POCD will be determined via neurological assessment according to diagnostic criteria.
Should associations between zinc status, POCD biomarkers, inflammation, cognitive performance and POCD incidence be established, not only would it lead to future work to investigate potential mechanisms of action as well as intervention studies looking to support zinc status, optimising early identification of individuals who may be at higher risk of developing POCD should lead to better patient outcomes.
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Detailed Description
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Participation will involve testing on 3 occasions: 48hours-3 weeks prior to surgery (in the participant's home), 1-3 days post-surgery (in the Royal Berkshire Hospital) and approximately one month post-surgery (in the participant's home).
On each occasion, the Montreal Cognitive Assessment (MoCA) and Confusion Assessment Method (CAM) will be administered along with various cognitive tests measuring executive function (Trials A \& B, Stroop, Letter memory task, verbal fluency) and memory (the episodic memory tests of free recall and recognition from the CERAD: Consortium to Establish a Registry for Alzheimer's Disease neuropsychological test battery), as well as completion of questionnaires to determine mood (the Hospital Anxiety and Depression Scale \[HADS\] and the Positive and Negative Affect Scale \[PANAS\]) and sleep quality (the Pittsburgh Sleep Quality Index). The cognitive testing should take approximately 30-40 minutes.
At the first session (pre-operation) only, dietary information will also be collected via a food frequency questionnaire, as well as measures of fluid and crystallised intelligence (the National Adult Reading Test and Block Design from the Wechsler Adult Intelligence Scale - Revised respectively).
In addition, at each visit, a blood sample (maximum volume of 9mL, less than one tablespoon) will be taken from the participants for analysis of zinc concentration and markers of POCD and inflammation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Elective surgery group
Patients undergoing hip/knee replacements or colorectal surgery will be recruited and tested on 3 occasions: pre-op, post-op and at follow-up. POCD status will be determined at post-op and follow up. Cognitive function, zinc status, POCD biomarkers and inflammatory markers will be measured on all 3 occasions.
Elective surgery
Patients will be scheduled to undergo elective orthopaedic (knee/hip replacement) or colorectal surgery.
Interventions
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Elective surgery
Patients will be scheduled to undergo elective orthopaedic (knee/hip replacement) or colorectal surgery.
Eligibility Criteria
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Inclusion Criteria
* Able to provide fully informed consent
* Scheduled to undergo orthopaedic (knee/hip replacement) or colorectal surgery
* English as their primary language
Exclusion Criteria
* Unable to provide fully informed consent
* English not their primary language
* Not electing to undergo any surgery or surgery that is not a knee or hip replacement, or colorectal surgery
60 Years
100 Years
ALL
No
Sponsors
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Royal Berkshire NHS Foundation Trust
OTHER_GOV
University of Reading
OTHER
Responsible Party
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Prof Claire Williams
Professor
Principal Investigators
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Claire Williams, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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School of Psychology and Clinical Languages, University of Reading
Reading, Berkshire, United Kingdom
Royal Berkshire Hospital
Reading, Berkshrie, United Kingdom
Countries
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Other Identifiers
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RDG-006
Identifier Type: -
Identifier Source: org_study_id
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