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

April 27, 2013 updated by: Chung-Hua Hsu, Taipei City Hospital

Taipei City Hospital, Taipei, Taiwan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Percent change Homa insulin resistance, cholesterol and triglycerol.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 886
        • Taipei City Hospital
      • Taipei, Taiwan, 886
        • Chung-Hua Hsu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B formula
placebo
Dietary supplement: Placebo
500 mg . one capsule of placebo, 3 times per day
Experimental: A formula
Green tea extract
Dietary supplement: Green tea extract
500 mg . one capsule of green tea extract, 3 times per day
Other Names:
  • EGCG: Green tea extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change of HOMA insulin resistance and TG
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change of HbA1C and Cholesterol
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Collaborators

National Yang Ming University

Investigators

  • Principal Investigator: Chung-Hua Hsu, MD, PhD, Taipei City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 27, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100002-63-020
  • TCH-971103 (Other Grant/Funding Number: CCMP100-RD-014)
  • TCHIRB-971103 (Other Grant/Funding Number: CCMP100-RD-014)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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