Haemodialysis fMRI Salt Appetite Study

Launched by IMPERIAL COLLEGE LONDON · Jul 4, 2019

Keywords

ClinConnect Summary

The Haemodialysis fMRI Salt Appetite Study is a clinical trial that aims to understand how the removal of salt and water during haemodialysis affects brain activity when tasting different levels of salt in soup. Researchers will use a special brain imaging technique called functional MRI (fMRI) to see how the brain responds to salt before and after the dialysis treatment. The study will focus on male patients who are on haemodialysis, particularly looking at those who gain weight between dialysis sessions versus those who do not.

To participate in this study, individuals must be male, aged 18 to 65, and must have been on haemodialysis for at least six months. Participants should be able to undergo a one-hour MRI scan and have specific levels of weight gain between dialysis sessions. Throughout the trial, participants will taste soups with different salt concentrations while their brain activity is monitored. This research could help improve understanding of salt cravings and weight gain in patients undergoing dialysis, which is important for their overall health.

Gender

MALE

Eligibility 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