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Clinical Trial Details

Trial ID: L6815
Source ID: NCT02627898
Associated Drug: Green Tea Extract
Title: Effect of Green Tea Extract on Arterial Stiffness in Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: green tea extract|DRUG: placebo
Outcome Measures: Primary: Change from Baseline in Aortic Pulse Wave Velocity measured in meters / second, at 12 weeks, Before and after intervention with oscillometric monitoring system via BPLab, baseline and 12 weeks | Secondary: Change from Baseline in aortic pulse pressure measured in mm / Hg at 12 weeks, Before and after intervention with oscillometric monitoring system via BPLab, baseline and 12 weeks|Change from Baseline in aortic Augmentation index measured in percentage at 12 weeks, Before and after intervention with oscillometric monitoring system via BPLab, baseline and 12 weeks|Change from Baseline in central systolic blood pressure measured in mm / Hg at 12 weeks, Before and after intervention with oscillometric monitoring system via BPLab, baseline and 12 weeks | Other: Change from Baseline in Fasting plasma glucose measured in mg / dL at 12 weeks, Before and after intervention by spectrophotometry, baseline and 12 weeks|Change from Baseline in Total cholesterol measured in mg / dL at 12 weeks, Before and after intervention by spectrophotometry, baseline and 12 weeks|Change from Baseline in Triglycerids measured in mg / dL at 12 weeks, Before and after intervention by spectrophotometry, baseline and 12 weeks|Change from Baseline in High-density lipoprotein colesterol measured in mg / dL at 12 weeks, Before and after intervention by friedewall formula, baseline and 12 weeks|Change from Baseline in Low-density lipoprotein colesterol measured in mg / dL at 12 weeks, Before and after intervention by friedewall formula, baseline and 12 weeks|Change from Baseline in Alanine aminotransferase measured in IU / L at 12 weeks, Before and after intervention by spectrophotometry, baseline and 12 weeks|Change from Baseline in Aspartate aminotransferase measured in IU / L at 12 weeks, Before and after intervention by spectrophotometry, baseline and 12 weeks|Change from Baseline in Creatinine measured in mg / dL at 12 weeks, Before and after intervention by spectrophotometry, baseline and 12 weeks|Change from Baseline in Peripheral systolic blood pressure measured in mg / dL at 12 weeks, Before and after intervention using a digital baumanometer, baseline and 12 weeks|Change from Baseline in Peripheral diastolic blood pressure measured in mg / dL at 12 weeks, Before and after intervention using a digital baumanometer, baseline and 12 weeks|Change from Baseline in Body and visceral fat measured in centimeters ^ 2 at 12 weeks, Before and after intervention using an impedance bascula, Dualscan HDS-2000, baseline and 12 weeks
Sponsor/Collaborators: Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-01
Completion Date: 2016-12
Results First Posted:
Last Update Posted: 2018-01-25
Locations:
URL: https://clinicaltrials.gov/show/NCT02627898