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Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas 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:
NCT00808860
First received: December 15, 2008
Last updated: December 3, 2010
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Dietary Supplement: GP group
Dietary Supplement: Placebo group
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hanoi Medical University:

Primary Outcome Measures:
  • fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HbA1C (glycosylated hemoglobin) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver enzymes (AST, ALT) [ 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-weight ratio) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group
Gliclazide + Placebo tea
 Dietary Supplement: Placebo group
Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
Active Comparator: GP group
Gliclazide + Gynostemma pentaphyllum tea
 Dietary Supplement: GP group
Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808860

Locations
Vietnam
National Institute of Gerontology, HMU
Hanoi, Vietnam
Sponsors and Collaborators
Hanoi Medical University
Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)
Investigators
Study Director: Claes-Goran Ostenson, MD, PhD Karolinska Institutet
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00808860     History of Changes
Other Study ID Numbers: Diabetes II-Study 2, Study 2
Study First Received: December 15, 2008
Last Updated: December 3, 2010
Health Authority: Vietnam: Ministry of Health

Keywords provided by Hanoi Medical University:
Herbal medicine
Type 2 diabetes
Gynostemma pentaphyllum Tea
Insulin sensitivity
add-on

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013