Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, drug-naive patients with type 2 diabetes
- •Fasting plasma glucose (FPG) 7.0-14.0 mmol/l
- •HbA1c > 6%
排除标准
- •Type 1 diabetes
- •Liver failure
- •Kidney Failure
结局指标
主要结局
Fasting plasma glucose
时间窗: 12 weeks
HbA1c (glycosylated hemoglobin)
时间窗: 12 weeks
次要结局
- Liver enzymes (ALT, AST)(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-waist ratio)(12 weeks)