Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- HOMA index
研究概览
简要总结
The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet
详细描述
Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.
However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.
It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.
Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 25 and 40 years old
- •Diagnosis of insulin resistance (HOMA ≥2.5)
- •26≤ BMI ≤32
排除标准
- •Subjects with no indication for treatment
- •Pregnancy and breastfeeding
- •Treatment with drugs or supplements that interfere with the mechanism of action of insulin
结局指标
主要结局
HOMA index
时间窗: Three time points: change in HOMA index from the baseline to 2 and 4 months
Reduction of HOMA index
次要结局
未报告次要终点