- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00567905
Effect of Green Tea Extract on Type 2 Diabetes (GTT-DM)
Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 886
- Branch of Chinese Medicine, Taipei City Hospital
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Taipei, Taiwan, 886
- Branch of Chinese Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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
|
main content is epigallocatechin gallate (EGCG, 58%)
Other Names:
|
Experimental: A
Green tea extract
|
main content is epigallocatechin gallate (EGCG, 58%)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
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---.
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Chung-Hua Hsu, MD; PhD, Branch of Chinese Medicine, Taipei City Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tpe-2007-IRB-05
- NSC-96-2320-13-192-001
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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