Effect of Green Tea Extract on Type 2 Diabetes

NCT ID: NCT00567905

Last Updated: 2009-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-08-31

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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Green tea extract

Group Type EXPERIMENTAL

Green tea extract

Intervention Type DIETARY_SUPPLEMENT

main content is epigallocatechin gallate (EGCG, 58%)

B

Group Type PLACEBO_COMPARATOR

Green tea extract

Intervention Type DIETARY_SUPPLEMENT

main content is epigallocatechin gallate (EGCG, 58%)

Interventions

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Green tea extract

main content is epigallocatechin gallate (EGCG, 58%)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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A:GTE (500 mg) tid/day B:Placebo (cellulose, 500 mg) tid/day

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei Hospital, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Taipei Hospital

Principal Investigators

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Chung-Hua Hsu, MD; PhD

Role: STUDY_CHAIR

Branch of Chinese Medicine, Taipei City Hospital

Locations

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Branch of Chinese Medicine, Taipei City Hospital

Taipei, , Taiwan

Site Status

Branch of Chinese Medicine

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Kao YH, Chang HH, Lee MJ, Chen CL. Tea, obesity, and diabetes. Mol Nutr Food Res. 2006 Feb;50(2):188-210. doi: 10.1002/mnfr.200500109.

Reference Type BACKGROUND
PMID: 16416476 (View on PubMed)

Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.

Reference Type DERIVED
PMID: 21649457 (View on PubMed)

Other Identifiers

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NSC-96-2320-13-192-001

Identifier Type: -

Identifier Source: secondary_id

Tpe-2007-IRB-05

Identifier Type: -

Identifier Source: org_study_id

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