DialysisHeMSANCT04011254
Haemodialysis fMRI Salt Appetite Study
An observational study of Dialysis and Excess Interdialytic Weight Gain, run by Imperial College London at 1 site in United Kingdom.
Trial summary
1. 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. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dialysis, Excess Interdialytic Weight Gain
- What is being tested?
- haemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Haemodialysis patients under the care of Imperial College NHS Healthcare Trust and healthy controls
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0NN
Eleanor C Sandhu, MBBS, 020331333980, eleanor.sandhu@ic.ac.uk
Tony Goldstone, MRCP PhD, 020 7594 5989, tony.goldstone@imperial.ac.uk
About this study
Official title: 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
Read the 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.
- Conditions
- Dialysis, Excess Interdialytic Weight Gain
- Being tested
- haemodialysis
- Keywords
- salt taste preference, salt taste sensitivity, functional Magnetic Resonance Imaging, Dialysis, Salt taste, salt intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haemodialysisProcedure or surgery
Routine haemodialysis session
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy control | |
| Haemodialysis %IDWG >4% | Patient on regular haemodialysis with average IDWG >4% Receives: Procedure: haemodialysis | |
| Haemodialysis %IDWG <4% | Patient on regular haemodialysis with average IDWG <4% Receives: Procedure: haemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in regional brain BOLD signal during tasting of soup of differing salt concentrations (vs. artificial saliva) pre dialysis session verse post dialysis session
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,
Measured: 1 week (maximal time between pre and post dialysis scan)
Secondary outcomes (6)
Change in ratings of salt liking and intensity across different salt concentrations of soup
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
Measured: 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
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
Measured: 1 week (maximal time between pre and post dialysis scan)
Ratings of sour liking and intensity
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
Measured: 1 week (maximal time between pre and post dialysis scan)
Salt threshold testing
The lowest concentration of saline solution detected by taste. pre dialysis session verse post dialysis session
Measured: 1 week (maximal time between pre and post dialysis scan)
Arterial spin labelling
arterial spin labelling measurement of regional cerebral blood flow at rest pre dialysis session verse post dialysis session
Measured: 1 week (maximal time between pre and post dialysis scan)
cerebral vascular reactivity pre dialysis session verse post dialysis session
BOLD signal changes during breath hold to assess BOLD signal reactivity to increased CO2 concentrations
Measured: 1 week (maximal time between pre and post dialysis scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start17 Feb 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Forschungszentrum Juelich
- Responsible party
- Sponsor
- Investigators
- Eleanor C Sandhu, MBBS, Principal investigator, Imperial College LondonTony Goldstone, MRCP PhD, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011254
- Sponsor's protocol ID
- 19HH5153
- Acronym
- HeMSA
- Status last verified
- Apr 2023
- First submitted
- 25 Jun 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04011254
- Acronym / sponsor ID
- HeMSA / 19HH5153
- Conditions
- Dialysis, Excess Interdialytic Weight Gain
- Keywords
- salt taste preference, salt taste sensitivity, functional Magnetic Resonance Imaging, Dialysis, Salt taste, salt intake
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Yale University, Forschungszentrum Juelich
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Healthy control |
| Haemodialysis %IDWG >4% | – | Procedure: haemodialysisPatient on regular haemodialysis with average IDWG >4% |
| Haemodialysis %IDWG <4% | – | Procedure: haemodialysisPatient on regular haemodialysis with average IDWG <4% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Haemodialysis patients under the care of Imperial College NHS Healthcare Trust and healthy controls
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| haemodialysisRoutine haemodialysis session | Procedure or surgery | Haemodialysis %IDWG <4%, Haemodialysis %IDWG >4% |
Primary outcome
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,
6 secondary outcomes
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)
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 sour liking and intensity
Time frame: 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)
Arterial spin labelling
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor C Sandhu, MBBS principal investigator
Imperial College London
Tony Goldstone, MRCP PhD study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis and Excess Interdialytic Weight Gain, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleanor C Sandhu, MBBS (02033133980, eleanor.sandhu@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.