Haemodialysis fMRI Salt Appetite Study

Dialysis Clinical Trial

— HeMSA  

Official title:

Examining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011254
• Other study ID #: 19HH5153
• Status: Recruiting
• Start date: February 17, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Imperial College London
• Contact: Eleanor C Sandhu, MBBS
• Phone: 02033133980
• Email: eleanor.sandhu[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Excess Interdialytic Weight Gain
• Weight Gain

Intervention

Procedure:
• haemodialysis
Routine haemodialysis session

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Forschungszentrum Juelich, Yale University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	1 week (maximal time between pre and post dialysis scan)
Secondary	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	1 week (maximal time between pre and post dialysis scan)
Secondary	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	1 week (maximal time between pre and post dialysis scan)
Secondary	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	1 week (maximal time between pre and post dialysis scan)
Secondary	Salt threshold testing	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)
Secondary	Arterial spin labelling	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)
Secondary	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	1 week (maximal time between pre and post dialysis scan)