Clinical trial NCT00567905: Effect of Green Tea Extract on Type 2 Diabetes
Official title: Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Green tea extract
overweight
Lead sponsor: Taipei Hospital, Taiwan
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2007-12-05
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of green tea extract (GTE) on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.

Detailed description: Green tea is one of the most popular beverages in the world. It is believed to have beneficial effects in prevention and treatment of many diseases, one of which is anti-obesity and anti-diabetes.

The benefit effects of green tea are mainly attributed to its polyphenol content, especially the most abundant one-epigallocatechin gallate (EGCG), which might inhibit adipocyte proliferation and differentiation in vitro studies

We hypothesized that GTE would improve insulin resistance in type 2 overweight diabetes and related hormone peptides will be influenced. Thus, we conducted this randomized clinical trial to examine the effect of GTE on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Body mass index \>25 kg/mm
* Aged between 20 and 65 years
* Being Chinese

Exclusion Criteria:

* Aminotransferases aspartate or aminotransferases alanine \> 80 IU/L, serum creatinine \> 2.0 mg/dl,
* Prolating or pregnant women, and patients with heart failure, acute myocardiac infarct, stroke and heavy injuries, and
* Any other conditions not suitable for trial as evaluated by the physician.

Primary outcomes:
measure: Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.
timeFrame: 16 weeks
Secondary outcomes:
measure: HbA1C, blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid, and plasma lipoproteins (triglyceride, cholesterol, cholesterol-HDL (HDL) and cholesterol-LDL (LDL)) cholesterol; BMI,WC---.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Branch of Chinese Medicine, Taipei City Hospital
city: Taipei
country: Taiwan
facility: Branch of Chinese Medicine
Study officials:
affiliation: Branch of Chinese Medicine, Taipei City Hospital
name: Chung-Hua Hsu, MD; PhD
role: STUDY_CHAIR
References:
citation: Kao YH, Chang HH, Lee MJ, Chen CL. Tea, obesity, and diabetes. Mol Nutr Food Res. 2006 Feb;50(2):188-210. doi: 10.1002/mnfr.200500109.
citation: Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.