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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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, 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 August 18, 2014