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

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ClinicalTrials.gov Identifier: NCT00808860
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : December 6, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: GP group Dietary Supplement: Placebo group Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Study Start Date : February 2008
Primary Completion Date : October 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. fasting plasma glucose [ Time Frame: 12 weeks ]
  2. HbA1C (glycosylated hemoglobin) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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