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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally
Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
National Institute of Gerontology, HMU
Hanoi, Vietnam
fasting plasma glucose
Time frame: 12 weeks
HbA1C (glycosylated hemoglobin)
Time frame: 12 weeks
liver enzymes (AST, ALT)
Time frame: 12 weeks
kidney function (S-creatinine, S-BUN)
Time frame: 12 weeks
plasma lipids (TG, Cholesterol, HDL-, LDL-)
Time frame: 12 weeks
blood pressure
Time frame: 12 weeks
body weight (BMI, hip-weight ratio)
Time frame: 12 weeks
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