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

NCT ID: NCT01360567

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Percent change Homa insulin resistance, cholesterol and triglycerol.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Hyperlipidemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

green tea EGCG type 2 diabetes hyperlipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B formula

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

500 mg . one capsule of placebo, 3 times per day

A formula

Green tea extract

Group Type EXPERIMENTAL

Green tea extract

Intervention Type DIETARY_SUPPLEMENT

500 mg . one capsule of green tea extract, 3 times per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Green tea extract

500 mg . one capsule of green tea extract, 3 times per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

500 mg . one capsule of placebo, 3 times per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EGCG: Green tea extract

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Yang Ming Chiao Tung University

OTHER

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chung-Hua Hsu

chief medical officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chung-Hua Hsu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei City Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chung-Hua Hsu

Taipei, , Taiwan

Site Status

Taipei City Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18468736 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24614112 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TCH-971103

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TCHIRB-971103

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

100002-63-020

Identifier Type: -

Identifier Source: org_study_id