Effect of Green Tea Extract on Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of green tea extract (GTE) on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.

Detailed Description
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Green tea is one of the most popular beverages in the world. It is believed to have beneficial effects in prevention and treatment of many diseases, one of which is anti-obesity and anti-diabetes. The benefit effects of green tea are mainly attributed to its polyphenol content, especially the most abundant one-epigallocatechin gallate (EGCG), which might inhibit adipocyte proliferation and differentiation in vitro studies We hypothesized that GTE would improve insulin resistance in type 2 overweight diabetes and related hormone peptides will be influenced. Thus, we conducted this randomized clinical trial to examine the effect of GTE on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.

Official Title
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Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Green tea extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Body mass index >25 kg/mm Aged between 20 and 65 years Being Chinese Exclusion Criteria: Aminotransferases aspartate or aminotransferases alanine > 80 IU/L, serum creatinine > 2.0 mg/dl, Prolating or pregnant women, and patients with heart failure, acute myocardiac infarct, stroke and heavy injuries, and Any other conditions not suitable for trial as evaluated by the physician.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Green tea extract | Dietary Supplement: Green tea extract<br>* main content is epigallocatechin gallate (EGCG, 58%)<br>* Other names: B:Placebo (cellulose, 500 mg) tid/day;|
| Placebo Comparator: B<br> | Dietary Supplement: Green tea extract<br>* main content is epigallocatechin gallate (EGCG, 58%)<br>* Other names: B:Placebo (cellulose, 500 mg) tid/day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C, blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid, and plasma lipoproteins (triglyceride, cholesterol, cholesterol-HDL (HDL) and cholesterol-LDL (LDL)) cholesterol; BMI,WC---. |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Green tea extract, overweight