The main objectives of this study were to evaluate the effect of a 12-week supplementation with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with T2DM.
A 12 week randomized double-blind, placebo-controlled trial was conducted in patients with T2DM to evaluate the effect of green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs) on lipids, anthropometric variables, arterial stiffness and inflammatory cytokines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
400 mg capsule
400 mg capsule
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico
Change from baseline in cholesterol at week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time frame: baseline and week 12
Change from baseline in HDL at week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time frame: baseline and week 12
Change from baseline in LDL at week 12
Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5)
Time frame: baseline and week 12
Change from baseline in triglycerides at week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time frame: baseline and week 12
Change from baseline in VLDL at week 12
Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)
Time frame: baseline and week 12
Change from baseline in augmentation index at week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time frame: baseline and week 12
Change from baseline in pulse pressure at week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time frame: baseline and week 12
Change from baseline in central systolic blood pressure at week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
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Time frame: baseline and week 12
Change from baseline in IL-6 at week 12
Measurement was done using commercially available ELISA kits from Peprotech
Time frame: baseline and week 12
Change from baseline in IL-1β at week 12
Measurement was done using commercially available ELISA kits from Peprotech
Time frame: baseline and week 12
Change from baseline in TNF-α at week 12
Measurement was done using commercially available ELISA kits from Peprotech
Time frame: baseline and week 12
Change from baseline in glucose at week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time frame: baseline and week 12
Change from baseline in Hemoglobin A1c at week 12
Measured using the Bio-Rad Variant Classic Hemoglobin testing system
Time frame: baseline and week 12
Change from baseline in systolic blood pressure at week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time frame: baseline and week 12
Change from baseline in diastolic blood pressure at week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time frame: baseline and week 12
Change from baseline in IMC at week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
Time frame: baseline and week 12
Change from baseline in body fat percentage at week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
Time frame: baseline and week 12
Change from baseline in fat mass at week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
Time frame: baseline and week 12
Change from baseline in lean mass at week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
Time frame: baseline and week 12
Change from baseline in body water at week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
Time frame: baseline and week 12