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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
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital

Study Description
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Brief Summary:
The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Hyperlipidemia Dietary Supplement: Green tea extract Dietary Supplement: Placebo Phase 3

Detailed Description:
Percent change Homa insulin resistance, cholesterol and triglycerol.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percent change of HOMA insulin resistance and TG [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Percent change of HbA1C and Cholesterol [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Taiwan
Chung-Hua Hsu
Taipei, Taiwan, 886
Taipei City Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Taipei City Hospital
National Yang Ming University
Investigators
Principal Investigator: Chung-Hua Hsu, MD, PhD Taipei City Hospital
More Information
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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

Keywords provided by Chung-Hua Hsu, Taipei City Hospital:
green tea
EGCG
type 2 diabetes
hyperlipidemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperlipidemias
Hyperlipoproteinemias
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders