Status:
UNKNOWN
Haemodialysis fMRI Salt Appetite Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Yale University
Forschungszentrum Juelich
Conditions:
Dialysis
Excess Interdialytic Weight Gain
Eligibility:
MALE
18-65 years
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) durin...
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 comp...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04011254
Start Date
February 17 2020
End Date
December 31 2025
Last Update
April 14 2023
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0NN