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Effect of Green Tea Extract on Type 2 Diabetes (GTT-DM)

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00567905
First received: December 4, 2007
Last updated: January 12, 2009
Last verified: January 2009
History of Changes

December 4, 2007
January 12, 2009
September 2007
August 2008   (final data collection date for primary outcome measure)
Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00567905 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Green Tea Extract on Type 2 Diabetes
Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
Dietary Supplement: Green tea extract
main content is epigallocatechin gallate (EGCG, 58%)
Other Names:
  • A:GTE (500 mg) tid/day
  • B:Placebo (cellulose, 500 mg) tid/day
  • Experimental: A
    Green tea extract
    Intervention: Dietary Supplement: Green tea extract
  • Placebo Comparator: B
    Intervention: Dietary Supplement: Green tea extract

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00567905
Tpe-2007-IRB-05, NSC-96-2320-13-192-001
Yes
Chung-Hua Hsu, Taipei Hospital
Taipei Hospital, Taiwan
National Science Council, Taiwan
Study Chair: Chung-Hua Hsu, MD; PhD Branch of Chinese Medicine, Taipei City Hospital
Taipei Hospital, Taiwan
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP