HeMSAExamining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 17, 2020
Actual date on which the first participant was enrolled.HeMSA Study Phase 2 Up to 20 male, haemodialysis patient who have average %IDWG >4% will be recruited with the target, to proceed to scanning, of 14 patients. Following consent the patients will complete questionnaires (including Salt intake questionnaire - DSQ (Gkza and Davenport, 2017), Edinburgh handedness questionnaire (Oldfield, 1971), MRI checklist) and undergo salt taste preference and threshold testing during a 1 hour session prior to dialysis. The purpose of this visit is to establish the tasteless solution and 2 soup salt concentrations to be used in the salt taste fMRI paradigm, obtain baseline data regarding estimate of salt intake and ensure MRI is safe for this patient. Patients will then attend 2 MRI scanning visits at the Hammersmith Hospital Imperial Campus, one the morning immediately before haemodialysis and one the morning after haemodialysis. Prior to the MRI session, at the Imperial College Clinical Research Facility, the patient will undergo various clinical assessments and have venous blood samples taken. The MRI will be undertaken at the Imperial College Clinical Imaging Facility using a Siemens 3T Verio scanner. During the scan subjects will taste, via a taste delivery system, aliquots of tasteless solution, sucralose, and 2 soup with different concentrations of salt. Solutions will be delivered in a block design. HeMSA Study Phase 3 3 groups (healthy controls, haemodialysis (HD) patients with %IDWG <4%, haemodialysis patients with %IDWG >4% - patients froms phase 2 will contribute to the latter group) Protocol will follow that for HeMSA Phase 2. Healthy controls will also have 2 study visits at a similar period apart to the HD participants.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: All participants: * Male * Aged 18-65 years * Non-smoker (ex-smokers allowed) * Right handed (able to use a right handed response button) * Able to tolerate 1 hour MRI scanning session For haemodialysis patients: * Established on haemodialysis for more than 6 months * Urine output \<200ml/24 hours * Average (over the past month) interdialytic weight gain: 1. Main phase 2: \>4 %IDWG 2. Main phase 3: \<4 or \>4 %IDWG Exclusion Criteria: * Type 1 or type 2 diabetes mellitus * Current smoker * Uncontrolled depression (change in use of anti-depressants in last 3 months, or BDI-II score \>28/63) * Neurological disorder (Parkinson's disease, serious cerebrovascular disease, epilepsy, moderate-severe traumatic brain injury, dementia) * Previous bariatric surgery * Inflammatory state (CRP \>20 on routine dialysis blood tests) * Acute infective illness * Significant current or past medical or psychiatric history, or use of medications, that, in the opinion of the Investigators, contraindicates their participation, due to influence on outcome measures. * Patients lacking capacity or unable to consent and non-English language speakers * Contra-indication to MRI imaging e.g. metal insert, pacemaker * Claustrophobia * Patients currently participating in an active CTIMP trial, or within 4 half-lives of last administration of CTIMP product * Serious mental illness (e.g. bipolar disorder, schizophrenia) * Current alcohol or drug dependence
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Imperial College Healthcare NHS Trust
London, United KingdomOpen Imperial College Healthcare NHS Trust in Google Maps