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

Primary Purpose

Type 2 Diabetes, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Green tea extract
Placebo
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring green tea, EGCG, type 2 diabetes, hyperlipidemia

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung-Hua Hsu
  • Taipei City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

B formula

A formula

Arm Description

placebo

Green tea extract

Outcomes

Primary Outcome Measures

Percent change of HOMA insulin resistance and TG

Secondary Outcome Measures

Percent change of HbA1C and Cholesterol

Full Information

First Posted
May 20, 2011
Last Updated
April 27, 2013
Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT01360567
Brief Title
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
Official Title
Taipei City Hospital, Taipei, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.
Detailed Description
Percent change Homa insulin resistance, cholesterol and triglycerol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hyperlipidemia
Keywords
green tea, EGCG, type 2 diabetes, hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B formula
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
A formula
Arm Type
Experimental
Arm Description
Green tea extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea extract
Other Intervention Name(s)
EGCG: Green tea extract
Intervention Description
500 mg . one capsule of green tea extract, 3 times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
500 mg . one capsule of placebo, 3 times per day
Primary Outcome Measure Information:
Title
Percent change of HOMA insulin resistance and TG
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Percent change of HbA1C and Cholesterol
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Hua Hsu, MD, PhD
Organizational Affiliation
Taipei City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Hua Hsu
City
Taipei
ZIP/Postal Code
886
Country
Taiwan
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18468736
Citation
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.
Results Reference
background
PubMed Identifier
24614112
Citation
Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.
Results Reference
derived

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

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