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Clinical Trial Details

Trial ID: L7053
Source ID: NCT05542147
Associated Drug: Fenofibrate 145 Mg
Title: Genetic-Dependent Cardiovascular Response to PPAR-Alpha Agonist Fenofibrate
Acronym: MAGNETIC
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Cardiovascular Diseases|Pharmacogenomic Drug Interaction
Interventions: DRUG: Fenofibrate 145 mg|DRUG: Placebo
Outcome Measures: Primary: Endothelial Function, Differences in fenofibrate induced-changes in Reactive Hyperemia Index (RHI) across rs6008845 genotypes. \[RHI is a non-invasive measure of endothelial function, and it is inversely associated with risk of cardiovascular disease\]., baseline and 12 weeks | Secondary: Arterial Stiffness - Pulse Wave Velocity (PWV), Differences in fenofibrate induced-changes in PWV across rs6008845 genotypes. \[PWV is directly associated with risk of cardiovascular disease\], baseline and 12 weeks|Endothelial progenitor cells (EPCs), Differences in fenofibrate induced-changes in circulating levels of EPC across rs6008845 genotypes., baseline and 12 weeks|Inflammatory markers and chemokines, Differences in fenofibrate induced-changes in CCL11, CCL27 sVCAM, sE-Selectin, Endothelin-1 across rs6008845 genotypes., baseline and 12 weeks|Platelet aggregation induced by adenosine diphosphate (ADP), Anti-platelet effects will be evaluated as the differences in fenofibrate induced-changes in platelet aggregation induced by adenosine diphosphate (ADP) (i.e. ADPtest) across rs6008845 genotypes., baseline and 12 weeks|Platelet aggregation induced by arachidonic acid, Anti-platelet effects will be evaluated as the differences in fenofibrate induced-changes in platelet aggregation induced by arachidonic acid (ASPI test) across rs6008845 genotypes., baseline and 12 weeks | Other: Arterial Stiffness - Augmentation Index (AI), Differences in fenofibrate induced-changes in AI across rs6008845 genotypes, Baseline and 12 weeks|Haematopoietic stem/progenitor cells (HSPCs), Differences in fenofibrate induced-changes in circulating levels of HSPC across rs6008845 genotypes., Baseline and 12 weeks
Sponsor/Collaborators: Sponsor: Mario Luca Morieri
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-07-03
Completion Date: 2024-12-31
Results First Posted:
Last Update Posted: 2024-01-22
Locations: University Hospital of Padova, Padova, Padua, 35128, Italy
URL: https://clinicaltrials.gov/show/NCT05542147