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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: GP group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Gliclazide + Placebo tea | Dietary Supplement: Placebo group<br>* Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally<br>|
| Active Comparator: GP group<br>Gliclazide + Gynostemma pentaphyllum tea | Dietary Supplement: GP group<br>* Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose |  | 12 weeks | 
| HbA1C (glycosylated hemoglobin) |  | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herbal medicine, Type 2 diabetes, Gynostemma pentaphyllum Tea, Insulin sensitivity, add-on