Effect of Green Tea Extract on Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— GTT-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567905
• Other study ID #: Tpe-2007-IRB-05
• Secondary ID: NSC-96-2320-13-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 4, 2007
• Last updated: January 12, 2009
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: Taipei Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Green tea extract
main content is epigallocatechin gallate (EGCG, 58%)

Locations

Country	Name	City	State
Taiwan	Branch of Chinese Medicine	Taipei
Taiwan	Branch of Chinese Medicine, Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Hospital, Taiwan	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Kao YH, Chang HH, Lee MJ, Chen CL. Tea, obesity, and diabetes. Mol Nutr Food Res. 2006 Feb;50(2):188-210. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.		16 weeks
Secondary	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