Effect of Green Tea Extract on Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00567905
• Lead Sponsor: Taipei Hospital, Taiwan

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-12
• Last Update Posted: 2009-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.	16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Branch of Chinese Medicine, Taipei City Hospital; 🇨🇳 Taipei, Taiwan

Branch of Chinese Medicine; 🇨🇳 Taipei, Taiwan