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NCT Number: NCT00786500

Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients

The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Institute of Gerontology, HMU

Hanoi, Vietnam

About this study

In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. Based on previous results in experimental animals, we have selected the plant Gynostemma pentaphyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin secretion. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.

The present study aimed at investigate effects of GP extract, administered as a "tea", and compared with placebo in a randomized, double-blind trial in drug-naive patients with newly diagnosed type 2 diabetes. All patients also received instructions about diet and physical exercise. In addition to monitoring effects on plasma glucose regulation, we also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed, drug-naive patients with type 2 diabetes
  • Fasting plasma glucose (FPG) 7.0-14.0 mmol/l
  • HbA1c > 6%

Exclusion criteria

  • Type 1 diabetes
  • Liver failure
  • Kidney Failure

Treatment and study plan

Gynostemma Pentaphyllum tea

Dietary Supplement

3 grams twice daily, orally

Placebo tea

Dietary Supplement

3 grams twice daily, orally

Primary outcomes

  1. Fasting plasma glucose

    Time frame: 12 weeks

  2. HbA1c (glycosylated hemoglobin)

    Time frame: 12 weeks

Secondary outcomes

  1. Liver enzymes (ALT, AST)

    Time frame: 12 weeks

  2. Kidney function (S-creatinine, S-BUN)

    Time frame: 12 weeks

  3. Plasma lipids (TG, Cholesterol, HDL-, LDL-)

    Time frame: 12 weeks

  4. Blood pressure

    Time frame: 12 weeks

  5. Body weight (BMI, hip-waist ratio)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

  • Karolinska Institutet
  • Swedish International Development Cooperation Agency (SIDA)

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 6, 2008
Registry last updated
Dec 6, 2010

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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