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Clinical Trial Details

Trial ID: L3217
Source ID: NCT02327039
Associated Drug: Dapagliflozin
Title: The Effects of Dapagliflozin on HDL Particles Subtypes and Reverse Cholesterol Transport in Type 2 Diabetic Patients
Acronym: DAPA-HDL
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in reverse cholesterol transport, measured as cholesterol efflux capacity of patient's plasma, Detection of a significant change in reverse cholesterol transport by patients' plasma in Dapagliflozin compared to placebo-treated diabetic patients. The cholesterol efflux capacity of patient's plasma will be measured as arbitrary units using radioactive cholesterol loaded macrophages, 12 weeks | Secondary: Changes from baseline in HDL cholesterol levels, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients in HDL cholesterol levels, measured by standard chemistry in patients' serum, 12 weeks|Changes from baseline in the distribution in HDL subclasses, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients in the distribution of HDL subclasses (% distribution in each of the 10 HDL subclasses, measured with the Lipoprint system), 12 weeks|Changes from baseline in HDL antioxidant activity, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients in the HDL antioxidant activity, measured as serum concentrations of paraoxonase 1 (PON1), PON1 activity and TBARS., 12 weeks|Changes from baseline in CETP activity, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients in CETP activity, determined as U/ml using a commercially available assay, 12 weeks|Safety as measured by monitoring of adverse events, Safety and tolerability will be assessed during the study according to the protocol for monitoring of adverse events. Number of adverse events will be collected for each group, 12 weeks | Other: Exploratory analyses - changes from baseline in plasma cytokines, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients of the plasma concentrations of the following factors: IL-6, IL-8, PAI-1, TNF-α, visfatin, resistin, adiponectin, leptin, measured using multiplex arrays., 12 weeks|Exploratory analyses - changes from baseline in plasma bioimpedance body composition, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients of fat mass, fat-free mass and water, as determined by bioimpedance analysis., 12 weeks|Exploratory analyses - changes from baseline in impedance cardiography analysis, Detection of significant changes in Dapagliflozin compared to placebo-treated T2D patients of heart rate; stroke volume; cardiac output; acceleration index; velocity index; systolic time ratio; left ventricular ejection time; left cardiac work; left cardiac work index; systemic vascular resistance; thoracic fluid content; total arterial compliance, 12 weeks
Sponsor/Collaborators: Sponsor: University of Padova | Collaborators: Azienda Ospedaliera di Padova
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 33
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2015-03
Completion Date: 2016-09
Results First Posted:
Last Update Posted: 2019-08-02
Locations: Division of Metabolic Diseases, University Hospital of Padova, Padova, 35128, Italy
URL: https://clinicaltrials.gov/show/NCT02327039