Effect of Green Tea Extract on Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	Taipei Hospital, Taiwan National Science Council, Taiwan
Information provided by:	Taipei Hospital, Taiwan
ClinicalTrials.gov Identifier:	NCT00567905

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 II Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Cellulose Cellulose sodium phosphate Phosphocellulose Epigallocatechin gallate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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
A: Experimental Green tea extract	Dietary Supplement: Green tea extract main content is epigallocatechin gallate (EGCG, 58%)
B: Placebo Comparator	Dietary Supplement: Green tea extract main content is epigallocatechin gallate (EGCG, 58%)

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

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

Locations

Taiwan
Branch of Chinese Medicine, Taipei City Hospital
Taipei, Taiwan, 886
Branch of Chinese Medicine
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

NSC, taiwan This link exits the ClinicalTrials.gov site

Publications:

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

Responsible Party:	Taipei Hospital ( Chung-Hua Hsu )
Study ID Numbers:	Tpe-2007-IRB-05, NSC-96-2320-13-192-001
Study First Received:	December 4, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00567905
Health Authority:	Taiwan: Department of Health

Keywords provided by Taipei Hospital, Taiwan:

Type 2 Diabetes
Green tea extract
overweight

Study placed in the following topic categories:

Epigallocatechin gallate
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Overweight
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009