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

Study Overview
=================
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.

Official Title
-----------------
Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, Dyslipidemias, Arterial Stiffness

Intervention / Treatment
-----------------
* Dietary Supplement: Green tea extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients were randomly assigned to receive green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GTE<br>Green tea extract, 400 mg every 12 hours for 12 weeks | Dietary Supplement: Green tea extract<br>* 400 mg capsule<br>* Other names: Sunphenon 90D;|
| Placebo Comparator: Placebo<br>Calcined magnesia, 400 mg every 12 hours for 12 weeks | Dietary Supplement: Placebo<br>* 400 mg capsule<br>* Other names: Calcined magnesia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cholesterol at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 | 
| Change from baseline in HDL at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 | 
| Change from baseline in LDL at week 12 | Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5) | baseline and week 12 | 
| Change from baseline in triglycerides at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 | 
| Change from baseline in VLDL at week 12 | Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5) | 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 | 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 | 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 | baseline and week 12 | 
| Change from baseline in IL-6 at week 12 | Measurement was done using commercially available ELISA kits from Peprotech | baseline and week 12 | 
| Change from baseline in IL-1β at week 12 | Measurement was done using commercially available ELISA kits from Peprotech | baseline and week 12 | 
| Change from baseline in TNF-α at week 12 | Measurement was done using commercially available ELISA kits from Peprotech | baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glucose at week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer | baseline and week 12 | 
| Change from baseline in Hemoglobin A1c at week 12 | Measured using the Bio-Rad Variant Classic Hemoglobin testing system | 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 | 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 | baseline and week 12 | 
| Change from baseline in IMC at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 | 
| Change from baseline in body fat percentage at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 | 
| Change from baseline in fat mass at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 | 
| Change from baseline in lean mass at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 | 
| Change from baseline in body water at week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer | baseline and week 12 |