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

Hanoi Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: GP group

Study type: Interventional

Funder types: Other

Identifiers

NCT00808860

Diabetes II-Study 2

Study 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Gliclazide + Placebo tea

Treatment:

Dietary Supplement: Placebo group

GP group

Active Comparator group

Description:

Gliclazide + Gynostemma pentaphyllum tea

Treatment:

Dietary Supplement: GP group