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NCT Number: NCT00808860

Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4 and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver function.

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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 animal, the investigators have selected the plant Gynostemma pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2 diabetes.In addition to monitoring effects plasma glucose regulation, the investigators 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)9.0-14.0 mmol/L
  • HbA1C 9-13%

Exclusion criteria

  • Type 1 diabetes
  • Liver failure
  • Kidney failure

Treatment and study plan

GP group

Dietary Supplement

Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally

Placebo Group

Dietary Supplement

Gliclazide MR 30mg once a day, orally Placebo tea 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 (AST, ALT)

    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-weight 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
2008
Primary completion
2008
Study completion
2008
First posted
Dec 16, 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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