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

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)
Information provided by:
Hanoi Medical University
ClinicalTrials.gov Identifier:
NCT00786500
First received: November 5, 2008
Last updated: December 3, 2010
Last verified: November 2008

November 5, 2008
December 3, 2010
February 2007
September 2007   (final data collection date for primary outcome measure)
  • Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated hemoglobin) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786500 on ClinicalTrials.gov Archive Site
  • Liver enzymes (ALT, AST) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Kidney function (S-creatinine, S-BUN) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Plasma lipids (TG, Cholesterol, HDL-, LDL-) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Body weight (BMI, hip-waist ratio) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Dietary Supplement: Gynostemma pentaphyllum tea
    3 grams twice daily, orally
  • Dietary Supplement: Placebo tea
    3 grams twice daily, orally
  • Active Comparator: Gynostemma pentaphyllum tea
    Intervention: Dietary Supplement: Gynostemma pentaphyllum tea
  • Placebo Comparator: Placebo tea
    Intervention: Dietary Supplement: Placebo tea

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT00786500
Diabetes II, Study 1
No
Not Provided
Hanoi Medical University
  • Karolinska Institutet
  • Swedish International Development Cooperation Agency (SIDA)
Study Director: Claes Goran Ostenson, MD, PhD Karolinska Institutet
Hanoi Medical University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP