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Haemodialysis fMRI Salt Appetite Study (HeMSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011254
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Yale University
Forschungszentrum Juelich
Information provided by (Responsible Party):
Imperial College London

Brief 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. 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

Condition or disease Intervention/treatment
Dialysis Excess Interdialytic Weight Gain Procedure: haemodialysis

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Sodium

Group/Cohort Intervention/treatment
Healthy Control
Healthy control
Haemodialysis %IDWG >4%
Patient on regular haemodialysis with average IDWG >4%
Procedure: haemodialysis
Routine haemodialysis session

Haemodialysis %IDWG <4%
Patient on regular haemodialysis with average IDWG <4%
Procedure: haemodialysis
Routine haemodialysis session




Primary Outcome Measures :
  1. 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,


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Biospecimen Retention:   Samples With DNA
venous blood


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Haemodialysis patients under the care of Imperial College NHS Healthcare Trust and healthy controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011254


Contacts
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Contact: Eleanor C Sandhu, MBBS 02033133980 eleanor.sandhu@nhs.net
Contact: Tony Goldstone, BM ChB 02075945989 tony.goldstone@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0NN
Contact: Eleanor C Sandhu, MBBS    020331333980    eleanor.sandhu@ic.ac.uk   
Contact: Tony Goldstone, BM ChB    020 7594 5989    tony.goldstone@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Yale University
Forschungszentrum Juelich
Investigators
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Principal Investigator: Eleanor C Sandhu, MBBS Imperial College London
Study Director: Tony Goldstone, BM ChB Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04011254    
Other Study ID Numbers: 19HH5153
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
salt taste preference
salt taste sensitivity
functional Magnetic Resonance Imaging
Dialysis
Salt taste
salt intake
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight