Gynostemma Pentaphyllum Tea Improves Insulin Sensitivity 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
- 16
- 试验地点
- 2
- 主要终点
- Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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: 7-11 mmol/l
- •HbA1C: 7-9%.
排除标准
- •Type 1 diabetes
- •Liver and kidney failure
结局指标
主要结局
Fating plasma glucose, Steady state plasma glucose in Somatostatin-Insulin-Glucose Infusion Test
时间窗: 10 weeks
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).
次要结局
- 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)