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Clinical Trial Details

Trial ID: L6295
Source ID: NCT03298009
Associated Drug: Canagliflozin 100mg
Title: Impact of a Short-term Treatment With Canagliflozin (Canacardia-HF)
Acronym: Canacardia
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type2 Diabetes|Heart Failure
Interventions: DRUG: Canagliflozin 100mg|DRUG: Placebo oral capsule|RADIATION: PET imaging
Outcome Measures: Primary: Change to be observed with canagliflozin on myocardial dietary fatty acid uptake, will be assessed using oral administration of 18-fluoro-thiaheptadecanoic acid (\[18F\]-FTHA) with sequential dynamic. PET/CT scanning., 3 months|Change to be observed with canagliflozin on whole-body partitioning., will be assessed using oral administration of 18-fluoro-thiaheptadecanoic acid (\[18F\]-FTHA, with static PET/CT scanning, 3 months | Secondary: myocardial and liver NEFA uptake, using PET with \[11C\]-palmitate, 3 months|NEFA oxidative rate, using PET with \[11C\]-acetate, 3 months|plasma NEFA turnover, using i.v. infusion of \[U-13C\]-palmitate, 1 year | Other: Insulin sensitivity, will be determined using the HOMA-IR (based on fasting insulin and glucose levels), 1 year|Insulin secretion rate, will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters, 1 year|β-cell function, will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin, 1 year|hormonal response, will be determined using a multiplex assay system, 1 year|Biomarkers, Assays will be performed using the BIOPLEX, 1 year|body composition, DXA, 3 months
Sponsor/Collaborators: Sponsor: Université de Sherbrooke | Collaborators: Janssen Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2018-05-01
Completion Date: 2018-06-30
Results First Posted:
Last Update Posted: 2024-12-13
Locations:
URL: https://clinicaltrials.gov/show/NCT03298009