The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
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ClinicalTrials.gov Identifier: NCT01360567 |
Recruitment Status :
Completed
First Posted : May 25, 2011
Last Update Posted : April 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Hyperlipidemia | Dietary Supplement: Green tea extract Dietary Supplement: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Taipei City Hospital, Taipei, Taiwan |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | December 2012 |

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 Name: EGCG: Green tea extract |
- Percent change of HOMA insulin resistance and TG [ Time Frame: 16 weeks ]
- Percent change of HbA1C and Cholesterol [ Time Frame: 16 weeks ]

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360567
Taiwan | |
Chung-Hua Hsu | |
Taipei, Taiwan, 886 | |
Taipei City Hospital | |
Taipei, Taiwan, 886 |
Principal Investigator: | Chung-Hua Hsu, MD, PhD | Taipei City Hospital |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Chung-Hua Hsu, chief medical officer, Taipei City Hospital |
ClinicalTrials.gov Identifier: | NCT01360567 History of Changes |
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 ) |
First Posted: | May 25, 2011 Key Record Dates |
Last Update Posted: | April 30, 2013 |
Last Verified: | April 2013 |
green tea EGCG type 2 diabetes hyperlipidemia |
Diabetes Mellitus, Type 2 Hyperlipidemias Hyperlipoproteinemias Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Dyslipidemias Lipid Metabolism Disorders |