Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- glycaemia, insulinaemia, HOMA-IR
研究概览
简要总结
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.
OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and waist circumference
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
- None
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.
排除标准
- •Post-menopausal outpatients without metabolic syndrome
- •assumption of hypocholesterolemic or other insulin sensitizing drugs
研究组 & 干预措施
metformin
干预措施: Metformin (Drug)
myo-inositol
干预措施: myo-inositol (Dietary Supplement)
结局指标
主要结局
glycaemia, insulinaemia, HOMA-IR
时间窗: at baseline and after 6 months
次要结局
- serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference(at baseline and after six months)
研究者
Rosario D'anna
Associate Professor
University of Messina