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:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Camellia sinensis

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

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

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:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liu 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.


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, Type 2 Hyperlipidemias Diabetes Mellitus Dyslipidemias	Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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