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CompletedNCT01360567Updated Apr 30, 2013

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

A Phase 3 interventional study of Green tea extract and Placebo in Type 2 Diabetes and Hyperlipidemia, sponsored by Taipei City Hospital. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by Taipei City Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

Percent change Homa insulin resistance, cholesterol and triglycerol.

02

Conditions studied

  • Type 2 Diabetes
  • Hyperlipidemia

Keywords

  • green tea
  • EGCG
  • type 2 diabetes
  • hyperlipidemia
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 102 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Taipei City Hospital is the lead sponsor of 56 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 20--69 years old
  • Type 2 diabetes for > one year
  • TG >= 150 mg/dl or LDL >= 100 mg/dl

Exclusion criteria

Exclusion Criteria:

  • GPT > 80 mg/dl
  • Creatinine > 1.8 mg/dl
  • Pregnancy
  • AMI
  • Stroke
  • Operational or any not suitable patients diagnosis physician in charge
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
102 participants (actual)

Study arms

  • Placebo comparator
    B formula

    placebo

    Dietary Supplement: Placebo

  • Experimental
    A formula

    Green tea extract

    Dietary Supplement: Green tea extract

Interventions

  • Dietary supplementGreen tea extract

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

    Also known as: EGCG: Green tea extract

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Percent change of HOMA insulin resistance and TG

    Time frame: 16 weeks

Secondary outcomes

  1. Percent change of HbA1C and Cholesterol

    Time frame: 16 weeks

07

Study locations

2 sites
  • Chung-Hua Hsu
    Taipei, 886, Taiwan
  • Taipei City Hospital
    Taipei, 886, Taiwan
08

References and documents

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. PubMed 18468736 ↗
  • 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. PubMed 24614112 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01360567
Lead sponsor
Taipei City Hospital
Collaborators
National Yang Ming Chiao Tung University
Responsible party
Chung-Hua Hsu (chief medical officer, Taipei City Hospital) — Principal investigator
First posted
May 25, 2011
Start date
May 2011
Primary completion
Nov 2012
Completion
Dec 2012
Last update
Apr 30, 2013

Study contacts

Chung-Hua Hsu, MD, PhD
principal investigator · Taipei City Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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