Haemodialysis fMRI Salt Appetite Study

NCT04011254 | Unknown

• 1 other identifier: 19HH5153
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Conditions

Dialysis; Excess Interdialytic Weight Gain

Keywords

salt taste preference; salt taste sensitivity; functional Magnetic Resonance Imaging; Dialysis; Salt taste; salt intake

Outcome Measures

Primary Outcomes (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

  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 Outcomes (6)

• Change in ratings of salt liking and intensity across different salt concentrations of soup

  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

  1 week (maximal time between pre and post dialysis scan)

• Ratings of sour liking and intensity

  1 week (maximal time between pre and post dialysis scan)

• Salt threshold testing

  1 week (maximal time between pre and post dialysis scan)

• Arterial spin labelling

  1 week (maximal time between pre and post dialysis scan)

Study Arms (3)

Healthy Control

Healthy control

Haemodialysis %IDWG >4%

Patient on regular haemodialysis with average IDWG \>4%

Procedure: haemodialysis

Haemodialysis %IDWG <4%

Patient on regular haemodialysis with average IDWG \<4%

Procedure: haemodialysis

Interventions

haemodialysis PROCEDURE

Routine haemodialysis session

Haemodialysis %IDWG <4%; Haemodialysis %IDWG >4%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Haemodialysis patients under the care of Imperial College NHS Healthcare Trust and healthy controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Yale University: collaborator
• Forschungszentrum Juelich: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

venous blood

MeSH Terms

Interventions

Dialysis

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Eleanor C Sandhu, MBBS

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Tony Goldstone, MRCP PhD

  Imperial College London

  STUDY DIRECTOR

Central Study Contacts

Eleanor C Sandhu, MBBS

CONTACT

02033133980; eleanor.sandhu@nhs.net

Tony Goldstone, MRCP PhD

CONTACT

02075945989; tony.goldstone@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 8, 2019
• Study Start: February 17, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)