Effect of Green Tea Extract on Type 2 Diabetes
GTT-DM
2 other identifiers
interventional
32
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes
Started Sep 2007
Shorter than P25 for phase_2 type-2-diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJanuary 13, 2009
January 1, 2009
11 months
December 4, 2007
January 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.
16 weeks
Secondary Outcomes (1)
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
Study Arms (2)
A
EXPERIMENTALGreen tea extract
B
PLACEBO COMPARATORInterventions
main content is epigallocatechin gallate (EGCG, 58%)
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Body mass index \>25 kg/mm
- Aged between 20 and 65 years
- Being Chinese
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Branch of Chinese Medicine, Taipei City Hospital
Taipei, 886, Taiwan
Branch of Chinese Medicine
Taipei, 886, Taiwan
Related Publications (2)
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.
PMID: 16416476BACKGROUNDHsu 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.
PMID: 21649457DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chung-Hua Hsu, MD; PhD
Branch of Chinese Medicine, Taipei City Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 5, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
January 13, 2009
Record last verified: 2009-01