Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Glycaemic profile in response to mixed meal test
研究概览
简要总结
The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.
详细描述
This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.
The intervention is made of two phases including
- A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
- An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known type 2 diabetes
- •Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion
- •No acute complication of diabetes
- •HbA1C≤ 8%
排除标准
- •Infection up to 10 days prior to inclusion
- •Serum ALAT >3N,
- •MDRD estimated creatinine clearance <60ml/min
- •Tobacco smoking
结局指标
主要结局
Glycaemic profile in response to mixed meal test
时间窗: 1 month
Change in blood glucose profile during a mixed meal test at baseline and after one month intervention
次要结局
- insulin secretion in response to mixed meal test(1 month)
- Serum lipids(1 month)
- Insulin sensitivity(1 month)
- Liver enzymes(1 month)
研究者
Sobngwi Eugene
Professor
Yaounde Central Hospital