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Clinical Trial Details

Trial ID: L3285
Source ID: NCT03377335
Associated Drug: Dapagliflozin 10mg
Title: Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin 10mg|DRUG: Metformin
Outcome Measures: Primary: Subclinical atherosclerosis, To assess the effects of dapagliflozin on subclinical atherosclerosis, as assessed by carotid intima-media thickness (cIMT)., Change from baseline to 6 months of the treatment | Secondary: Endothelial dysfunction, To assess the effects of dapagliflozin on endothelial dysfunction through the evaluation of flow mediated dilation (FMD) of the brachial artery., Change from baseline to 6 months of the treatment|Oxidative stress, To assess the effects of dapagliflozin on oxidative stress including plasma glutathione, serum lipid hydroperoxides and reactive oxygen species., Change from baseline to 6 months of the treatment|Atherogenic lipoproteins, To assess the effects of dapagliflozin on atherogenic lipoproteins including the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis., Change from baseline to 6 months of the treatment|Inflammatory markers, To assess the effects of dapagliflozin on inflammatory markers, including plasma cytokines (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits., Change from baseline to 6 months of the treatment|microRNAs, To assess the effects of dapagliflozin on microRNAs. The miRNAs are endogenous 21-25 nucleotides noncoding RNA, and they are regulators of gene expression that post transcriptionally modify cellular responses and function. The miRNAs will be isolated from sera using the mirVana miRNA Isolation Kit (Ambion, Waltham, MA, USA), and then quantified by SYBR Green Real-Time (RT) polymerase chain reaction (PCR)., Change from baseline to 6 months of the treatment
Sponsor/Collaborators: Sponsor: University of Palermo | Collaborators: AstraZeneca|University of Catania
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 186
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-12-22
Completion Date: 2019-01
Results First Posted:
Last Update Posted: 2018-02-26
Locations: University Hospital of Palermo, Palermo, 90127, Italy
URL: https://clinicaltrials.gov/show/NCT03377335