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NCT Number: NCT00567905

Effect of Green Tea Extract on Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Branch of Chinese Medicine, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Green Tea Extract

Dietary Supplement

main content is epigallocatechin gallate (EGCG, 58%)

Other names: A:GTE (500 mg) tid/day, B:Placebo (cellulose, 500 mg) tid/day

Primary outcomes

  1. Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.

    Time frame: 16 weeks

Secondary outcomes

  1. 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---.

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Taipei Hospital, Taiwan

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Acronym: GTT-DM

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 5, 2007
Registry last updated
Jan 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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