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

May 20, 2011
April 27, 2013
May 2011
November 2012   (final data collection date for primary outcome measure)
Percent change of HOMA insulin resistance and TG [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01360567 on ClinicalTrials.gov Archive Site
Percent change of HbA1C and Cholesterol [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
Taipei City Hospital, Taipei, Taiwan

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

Percent change Homa insulin resistance, cholesterol and triglycerol.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Hyperlipidemia
  • Dietary Supplement: Green tea extract
    500 mg . one capsule of green tea extract, 3 times per day
    Other Name: EGCG: Green tea extract
  • Dietary Supplement: Placebo
    500 mg . one capsule of placebo, 3 times per day
  • Placebo Comparator: B formula
    placebo
    Intervention: Dietary Supplement: Placebo
  • Experimental: A formula
    Green tea extract
    Intervention: Dietary Supplement: Green tea extract

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01360567
100002-63-020, TCH-971103, TCHIRB-971103
Yes
Chung-Hua Hsu, Taipei City Hospital
Taipei City Hospital
National Yang Ming University
Principal Investigator: Chung-Hua Hsu, MD, PhD Taipei City Hospital
Taipei City Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP