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Clinical Trial Details

Trial ID: L6682
Source ID: NCT02610088
Associated Drug: Dapagliflozin
Title: Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Gliclazide
Outcome Measures: Primary: Vascular function assessed by Flow-mediated vasodilation (FMD), The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow (causing shear-stress) during reactive hyperaemia (induced by cuff inflation and then deflation). This leads to endothelium-dependent dilatation; the response is contrasted with that to sublingual nitroglycerin, an endothelium-independent dilator. The artery is scanned and the diameter measured during three conditions; at baseline, during reactive hyperaemia (induced by inflation and then deflation of a sphygmomanometer cuff around the limb, distal to the scanned part of the artery) and finally after administration of sublingual nitroglycerin (which causes endothelium-independent smooth muscle mediated vasodilatation)., 24weeks | Secondary: Change of blood pressure, 24weeks|Lipid metabolism assessed by triglyceride, low density lipoprotein-cholesterol and high density lipoprotein-cholesterol, 24weeks|Inflammatory markers assessed by hsCRP, 24weeks|Change of body composition assessed by bioelectrical impedance analysis (BIA) methods, 24weeks|Glucose metabolism assessed by glycated hemoglobin and fasting plasma glucose, 24weeks|Microcirculation assessed by laser doppler, 24weeks|Vascular health assessment by pulse wave velocity (PWV), PWV, by definition, is the distance traveled (Delta x) by the wave divided by the time (Delta t) for the wave to travel that distance, 24weeks|Vascular health assessment by Ankle-brachial index (ABI), The ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium)., 24weeks|Carotid intima-media thickness (cIMT) assessed by ultrasound, Intima-media thickness (IMT), also called intimal medial thickness, is a measurement of the thickness of tunica intima and tunica media, the innermost two layers of the wall of an artery., 24weeks
Sponsor/Collaborators: Sponsor: Seoul National University Bundang Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-11
Completion Date: 2018-09
Results First Posted:
Last Update Posted: 2018-09-11
Locations: Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02610088