Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on insulin sensitivity in drug-naïve type 2 diabetic patients.

Detailed Description
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In Vietnam, traditional herbal medicines have played a major role in the management of diabetes for centuries. Gynostemma Pentaphyllum (GP) Makino (Family Cucurbitaceae) is a perennial creeping herb growing wild in the mountainous regions of Vietnam, China and some other Asian countries and was widely used in Southeast Asian countries as an herbal medicine and being beneficial for the prevention and treatment of diabetes. We have previously published the evidences that GP tea possessed anti-diabetic effect with good safety data in newly diagnosed T2D patients, and had effect on insulin sensitivity. In addition extract of GP had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker Fatty rats. So the present study was to investigate the effects of Gynostemma Pentaphyllum tea in insulin sensitivity in type 2 diabetic patients.

Official Title
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Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Gynostemma Pentaphyllum tea
* Dietary Supplement: Placebo tea


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: 7-11 mmol/l HbA1C: 7-9%. Exclusion Criteria: Type 1 diabetes Liver and 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo tea<br>Dietary Supplement: Placebo tea 3 gram twice daily, orally | Dietary Supplement: Placebo tea<br>* 6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner<br>* Other names: Placebo extract;|
| Active Comparator: Gynostemma pentaphyllum Tea<br>Gynostemma Pentaphyllum tea 3 grams twice daily, orally | Dietary Supplement: Gynostemma Pentaphyllum tea<br>* 6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner<br>* Other names: Gynostemma Pentaphyllum extract;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test | All subjects participated in Somatostatin-Insulin-Glucose Infusion Test (SIGIT), lasting 150 minutes, performed at 8am after an 8-10h overnight fast with only tap water allowed ad libitum. Somatostatin was used to suppress endogenous insulin release, thereby allowing estimation of sensitivity to exogenously administered insulin by measuring blood glucose value at 90, 120 and 150 minute of the test (SIGIT mean). | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver enzymes (ALT, AST) |  | 10 weeks | 
| Kidney function (S-creatinine, S-BUN) |  | 10 weeks | 
| Plasma lipids (TG, Cholesterol, HDL-, LDL-) |  | 10 weeks | 
| Blood pressure |  | 10 weeks | 
| Body weight (BMI, hip-waist ratio) |  | 10 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;