Back to results

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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Green tea extract

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Green tea extract, overweight

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Green tea extract

Outcomes

Primary Outcome Measures

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

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---.

Full Information

NCT ID

NCT00567905

First Posted

December 4, 2007

Last Updated

January 12, 2009

Sponsor

Taipei Hospital, Taiwan

Collaborators

National Science Council, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT00567905

Brief Title

Effect of Green Tea Extract on Type 2 Diabetes

Acronym

GTT-DM

Official Title

Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Taipei Hospital, Taiwan

Collaborators

National Science Council, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 Diabetes, Green tea extract, overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Green tea extract

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Green tea extract

Other Intervention Name(s)

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

Intervention Description

main content is epigallocatechin gallate (EGCG, 58%)

Primary Outcome Measure Information:

Title

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

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chung-Hua Hsu, MD; PhD

Organizational Affiliation

Branch of Chinese Medicine, Taipei City Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Branch of Chinese Medicine, Taipei City Hospital

City

Taipei

ZIP/Postal Code

886

Country

Taiwan

Facility Name

Branch of Chinese Medicine

City

Taipei

ZIP/Postal Code

886

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

16416476

Citation

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.

Results Reference

background

PubMed Identifier

21649457

Citation

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.

Results Reference

derived

Learn more about this trial

Effect of Green Tea Extract on Type 2 Diabetes

We'll reach out to this number within 24 hrs