HeMSAExamining Salt Appetite in Haemodialysis Patients Using Functional Magnetic Resonance Imaging
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveCohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 17 février 2020
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.90 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Imperial College Healthcare NHS Trust
London, United KingdomOuvrir Imperial College Healthcare NHS Trust dans Google Maps