Type 2 Diabetes Clinical Trial
Official title:
Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.
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 animals, we have selected the plant Gynostemma pentaphyllum (GP),
which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect
on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin
secretion. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in
diabetic Zucker fatty rats.
The present study aimed at investigate effects of GP extract, administered as a "tea", and
compared with placebo in a randomized, double-blind trial in drug-naive patients with newly
diagnosed type 2 diabetes. All patients also received instructions about diet and physical
exercise. In addition to monitoring effects on plasma glucose regulation, we also studied
possible effects on plasma lipids, kidney and liver function as well as body weight and
blood pressure.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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