- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011254
Haemodialysis fMRI Salt Appetite Study (HeMSA)
Examining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging
- Assessing how the rapid removal of salt and water by haemodialysis alters regional brain activity (by measurement of the brain blood oxygen level-dependent (BOLD) signal using functional MRI) during tasting of soup of differing salt concentrations.
- Identify differences in the brain response to salt taste pre- and post-haemodialysis between haemodialysis patients who are either able or unable to control between dialysis weight gain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eleanor C Sandhu, MBBS
- Phone Number: 02033133980
- Email: eleanor.sandhu@nhs.net
Study Contact Backup
- Name: Tony Goldstone, MRCP PhD
- Phone Number: 02075945989
- Email: tony.goldstone@imperial.ac.uk
Study Locations
-
-
-
London, United Kingdom, W12 0NN
- Recruiting
- Imperial College Healthcare NHS Trust
-
Contact:
- Eleanor C Sandhu, MBBS
- Phone Number: 020331333980
- Email: eleanor.sandhu@ic.ac.uk
-
Contact:
- Tony Goldstone, MRCP PhD
- Phone Number: 020 7594 5989
- Email: tony.goldstone@imperial.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Main phase 2: >4 %IDWG
- 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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Control
Healthy control
|
|
Haemodialysis %IDWG >4%
Patient on regular haemodialysis with average IDWG >4%
|
Routine haemodialysis session
|
Haemodialysis %IDWG <4%
Patient on regular haemodialysis with average IDWG <4%
|
Routine haemodialysis session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in regional brain BOLD signal during tasting of soup of differing salt concentrations (vs. artificial saliva) pre dialysis session verse post dialysis session
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
Regional brain BOLD signal during tasting of soup of differing salt concentrations (vs.
artificial saliva) ROI including insula, amygdala, ventral tegmental area, pre frontal cortex,
|
1 week (maximal time between pre and post dialysis scan)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ratings of salt liking and intensity across different salt concentrations of soup
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
Ratings of liking, via Labelled Hedonic Scale (LHS) (-100=Most disliked sensation imaginable, 0=neural, 100=Most liked sensation imaginable), of salted soup of 2 concentrations pre dialysis session verse post dialysis session
|
1 week (maximal time between pre and post dialysis scan)
|
Change in ratings of sweet liking and intensity pre dialysis session verse post dialysis session
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
Ratings of liking and intensity, via Labelled Hedonic Scale (LHS) (-100=Most disliked sensation imaginable, 0=neural, 100=Most liked sensation imaginable), of sucralose solution
|
1 week (maximal time between pre and post dialysis scan)
|
Ratings of sour liking and intensity
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
Rating of liking and intensity, via Labelled Hedonic Scale (LHS) (-100=Most disliked sensation imaginable, 0=neural, 100=Most liked sensation imaginable) of citrate pre dialysis session verse post dialysis session
|
1 week (maximal time between pre and post dialysis scan)
|
Salt threshold testing
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
The lowest concentration of saline solution detected by taste.
pre dialysis session verse post dialysis session
|
1 week (maximal time between pre and post dialysis scan)
|
Arterial spin labelling
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
arterial spin labelling measurement of regional cerebral blood flow at rest pre dialysis session verse post dialysis session
|
1 week (maximal time between pre and post dialysis scan)
|
cerebral vascular reactivity pre dialysis session verse post dialysis session
Time Frame: 1 week (maximal time between pre and post dialysis scan)
|
BOLD signal changes during breath hold to assess BOLD signal reactivity to increased CO2 concentrations
|
1 week (maximal time between pre and post dialysis scan)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eleanor C Sandhu, MBBS, Imperial College London
- Study Director: Tony Goldstone, MRCP PhD, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19HH5153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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