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The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia

This study has been completed.
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01360567
First received: May 20, 2011
Last updated: April 27, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Hyperlipidemia
 Dietary Supplement: Green tea extract
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Taipei City Hospital, Taipei, Taiwan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei City Hospital:

Primary Outcome Measures:
  • Percent change of HOMA insulin resistance and TG [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change of HbA1C and Cholesterol [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Percent change Homa insulin resistance, cholesterol and triglycerol.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

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, TCHIRB-971103
Study First Received: May 20, 2011
Last Updated: April 27, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei City Hospital:
green tea
EGCG
type 2 diabetes
hyperlipidemia

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

ClinicalTrials.gov processed this record on May 16, 2013