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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo group; Dietary Supplement: GP group

• Registration Number: NCT00808860
• Lead Sponsor: Hanoi Medical University

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.

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 Timeline

• Study Start: 2008-02
• Primary Completion: 2008-10
• Status Verified: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	Gliclazide + Placebo tea
GP group	GP group	Gliclazide + Gynostemma pentaphyllum tea

Primary Outcome Measures

Name	Time	Method
HbA1C (glycosylated hemoglobin)	12 weeks
fasting plasma glucose	12 weeks

Secondary Outcome Measures

Name	Time	Method
liver enzymes (AST, ALT)	12 weeks
kidney function (S-creatinine, S-BUN)	12 weeks
body weight (BMI, hip-weight ratio)	12 weeks
plasma lipids (TG, Cholesterol, HDL-, LDL-)	12 weeks
blood pressure	12 weeks

Trial Locations

Locations (1)

National Institute of Gerontology, HMU; 🇻🇳 Hanoi, Vietnam