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CompletedNCT00567905GTT-DMUpdated Jan 13, 2009

Effect of Green Tea Extract on Type 2 Diabetes

A Phase 2/3 interventional study of Green tea extract in Type 2 Diabetes, sponsored by Taipei Hospital, Taiwan. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-01-13.

Sponsored by Taipei Hospital, Taiwan · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 Diabetes
  • Green tea extract
  • overweight
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 32 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Taipei Hospital, Taiwan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Body mass index >25 kg/mm
  • Aged between 20 and 65 years
  • Being Chinese

Exclusion criteria

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    A

    Green tea extract

    Dietary Supplement: Green tea extract

  • Placebo comparator
    B

    Dietary Supplement: Green tea extract

Interventions

  • Dietary supplementGreen tea extract

    main content is epigallocatechin gallate (EGCG, 58%)

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

06

What researchers measure

Primary outcomes

  1. Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.

    Time frame: 16 weeks

Secondary outcomes

  1. 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---.

    Time frame: 16 weeks

07

Study locations

2 sites
  • Branch of Chinese Medicine, Taipei City Hospital
    Taipei, 886, Taiwan
  • Branch of Chinese Medicine
    Taipei, 886, Taiwan
08

References and documents

Publications

  • 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. PubMed 16416476 ↗
  • 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. PubMed 21649457 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00567905
Lead sponsor
Taipei Hospital, Taiwan
Collaborators
National Science Council, Taiwan
First posted
Dec 5, 2007
Start date
Sep 2007
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Jan 13, 2009

Study contacts

Chung-Hua Hsu, MD; PhD
study chair · Branch of Chinese Medicine, Taipei City Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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