Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Basal Insulin
研究概览
简要总结
Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS.
In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml.
So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8-18 years old
- •overweight or obesity
- •basal insulin ≥ 20 uU/ml
排除标准
- •pubertal delay
- •hypogonadism
- •hypothyroidism or hyperthyroidism
- •obesity-related genetic diseases
研究组 & 干预措施
Inositol
Administration of Inofolic Combi (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg - Lo.Li Pharma S.r.l.) 2 capsules every day for 1 month
干预措施: Inofolic Combi (Dietary Supplement)
Placebo
Administration of placebo. 2 capsules every day for 1 month
干预措施: Placebo (Other)
结局指标
主要结局
Basal Insulin
时间窗: 1 month
Evaluation of the efficacy of inositol in reducing basal insulin
次要结局
- Body weight(1 month)
研究者
Alice Andreassi
Principal Investigator
Azienda Ospedaliera San Paolo