Effect of Green Tea Extract on Type 2 Diabetes | NCT00567905

Studies
Effect of Green Tea Extract on Type 2 Diabetes

NCT00567905

Sponsor

Taipei Hospital, Taiwan

Status

Completed

Last Update Posted

Jan 13, 2009Estimated

Enrollment

32Estimated

Phase

Phase 2Phase 3

Conditions

Type 2 Diabetes

Interventions

Green tea extract

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NSC-96-2320-13-192-001

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2009

Last Update Posted Date

Jan 13, 2009Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Green tea extract	Dietary Supplement: Green tea extract
B	Placebo Comparator		Dietary Supplement: Green tea extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Green tea extract	Dietary Supplement	main content is epigallocatechin gallate (EGCG, 58%)	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
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---.		16 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chung-Hua Hsu, MD; PhD	Branch of Chinese Medicine, Taipei City Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Branch of Chinese Medicine, Taipei City Hospital		Taipei		886	Taiwan
Branch of Chinese Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16416476	Background	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.
21649457	Derived	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.

Type	Date	Date Unknown
Release	Jan 13, 2009
Reset	Jan 27, 2009
Release	Jan 27, 2009
Reset	Jan 27, 2009
Release	Jan 30, 2009
Reset	Feb 25, 2009

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 12, 2009			Jan 12, 2009
Jan 13, 2009

ID	Term
D003924	Diabetes Mellitus, Type 2
D050177	Overweight

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D013662	Tea
D002482	Cellulose

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages