Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Dyslipidemias; Arterial Stiffness; Diabetes Mellitus, Type 2

• Registration Number: NCT04532385
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-06-12
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Status Verified: 2020-08
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-31
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with type 2 diabetes

Exclusion Criteria

• Type 1 diabetes
• Smoking patients
• Ischemic heart disease
• Use of anti-inflammatory or antioxidant drugs
• Previously diagnosed liver or thyroid disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in cholesterol at week 12	baseline and week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in IL-6 at week 12	baseline and week 12	Measurement was done using commercially available ELISA kits from Peprotech
Change from baseline in HDL at week 12	baseline and week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in triglycerides at week 12	baseline and week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in VLDL at week 12	baseline and week 12	Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)
Change from baseline in central systolic blood pressure at week 12	baseline and week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Change from baseline in LDL at week 12	baseline and week 12	Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5)
Change from baseline in IL-1β at week 12	baseline and week 12	Measurement was done using commercially available ELISA kits from Peprotech
Change from baseline in augmentation index at week 12	baseline and week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Change from baseline in pulse pressure at week 12	baseline and week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Change from baseline in TNF-α at week 12	baseline and week 12	Measurement was done using commercially available ELISA kits from Peprotech

Secondary Outcome Measures

Name	Time	Method
Change from baseline in glucose at week 12	baseline and week 12	Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in Hemoglobin A1c at week 12	baseline and week 12	Measured using the Bio-Rad Variant Classic Hemoglobin testing system
Change from baseline in diastolic blood pressure at week 12	baseline and week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Change from baseline in IMC at week 12	baseline and week 12	Measured with the Tanita TBF-215 Body Composition Analyzer
Change from baseline in lean mass at week 12	baseline and week 12	Measured with the Tanita TBF-215 Body Composition Analyzer
Change from baseline in body water at week 12	baseline and week 12	Measured with the Tanita TBF-215 Body Composition Analyzer
Change from baseline in systolic blood pressure at week 12	baseline and week 12	Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Change from baseline in body fat percentage at week 12	baseline and week 12	Measured with the Tanita TBF-215 Body Composition Analyzer
Change from baseline in fat mass at week 12	baseline and week 12	Measured with the Tanita TBF-215 Body Composition Analyzer

Trial Locations

Locations (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico