The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia

Type 2 Diabetes Clinical Trial

Official title:

Taipei City Hospital, Taipei, Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360567
• Other study ID #: 100002-63-020
• Secondary ID: TCH-971103TCHIRB
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2011
• Last updated: April 27, 2013
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.

Description:

Percent change Homa insulin resistance, cholesterol and triglycerol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 20--69 years old

• Type 2 diabetes for > one year

• TG >= 150 mg/dl or LDL >= 100 mg/dl

Exclusion Criteria:

• GPT > 80 mg/dl

• Creatinine > 1.8 mg/dl

• Pregnancy

• AMI

• Stroke

• Operational or any not suitable patients diagnosis physician in charge

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Green tea extract
500 mg . one capsule of green tea extract, 3 times per day
• Placebo
500 mg . one capsule of placebo, 3 times per day

Locations

Country	Name	City	State
Taiwan	Chung-Hua Hsu	Taipei
Taiwan	Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of HOMA insulin resistance and TG		16 weeks	Yes
Secondary	Percent change of HbA1C and Cholesterol		16 weeks	Yes