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

Phase 3

Completed

• Conditions: Type 2 Diabetes; Hyperlipidemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Green tea extract

• Registration Number: NCT01360567
• Lead Sponsor: Taipei City Hospital

Brief Summary

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

Detailed Description

Percent change Homa insulin resistance, cholesterol and triglycerol.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-27
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B formula	Placebo	placebo
A formula	Green tea extract	Green tea extract

Primary Outcome Measures

Name	Time	Method
Percent change of HOMA insulin resistance and TG	16 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change of HbA1C and Cholesterol	16 weeks

Trial Locations

Locations (2)

Taipei City Hospital; 🇨🇳 Taipei, Taiwan

Chung-Hua Hsu; 🇨🇳 Taipei, Taiwan