The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
Taipei City Hospital, Taipei, Taiwan
3 other identifiers
interventional
102
1 country
2
Brief Summary
The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes
Started May 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 30, 2013
April 1, 2013
1.5 years
May 20, 2011
April 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change of HOMA insulin resistance and TG
16 weeks
Secondary Outcomes (1)
Percent change of HbA1C and Cholesterol
16 weeks
Study Arms (2)
B formula
PLACEBO COMPARATORplacebo
A formula
EXPERIMENTALGreen tea extract
Interventions
500 mg . one capsule of green tea extract, 3 times per day
Eligibility Criteria
You may qualify if:
- Age 20--69 years old
- Type 2 diabetes for \> one year
- TG \>= 150 mg/dl or LDL \>= 100 mg/dl
You may not qualify if:
- GPT \> 80 mg/dl
- Creatinine \> 1.8 mg/dl
- Pregnancy
- AMI
- Stroke
- Operational or any not suitable patients diagnosis physician in charge
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei City Hospitallead
- National Yang Ming Chiao Tung Universitycollaborator
Study Sites (2)
Chung-Hua Hsu
Taipei, 886, Taiwan
Taipei City Hospital
Taipei, 886, Taiwan
Related Publications (2)
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.
PMID: 18468736BACKGROUNDLiu 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.
PMID: 24614112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Hua Hsu, MD, PhD
Taipei City Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief medical officer
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 25, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
April 30, 2013
Record last verified: 2013-04