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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Dietary Supplement: Green tea extract
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Taipei Hospital, Taiwan:

Primary Outcome Measures:
  • Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Green tea extract
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
Placebo Comparator: B 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00567905

Locations
Taiwan
Branch of Chinese Medicine
Taipei, Taiwan, 886
Branch of Chinese Medicine, Taipei City Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Taipei Hospital, Taiwan
National Science Council, Taiwan
Investigators
Study Chair: Chung-Hua Hsu, MD; PhD Branch of Chinese Medicine, Taipei City Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chung-Hua Hsu, Taipei Hospital
ClinicalTrials.gov Identifier: NCT00567905     History of Changes
Other Study ID Numbers: Tpe-2007-IRB-05, NSC-96-2320-13-192-001
Study First Received: December 4, 2007
Last Updated: January 12, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Hospital, Taiwan:
Type 2 Diabetes
Green tea extract
overweight

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014