Randomized, Controlled, Open-label Study to Evaluate the Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects With Type 2 Mellitus Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Glycated hemoglobin
研究概览
简要总结
Mellitus type 2 diabetes (T2MD) is a chronic disease characterized by high glucose plasmatic level due to an alteration of insulin function. Several authors have correlated this altered function to an inositol depletion. The main present member of inositol family in biological systems is undoubtedly myo-inositol, a precursor of several second messengers, widely involved in insulin signalling. For this reason this molecule is considered an insulin-sensitizer. The high excretion of inositol in T2MD patients is frequent, inducing a myo-inositol depleted state that favours the onset of insulin resistance, impairing the activity of this hormone. The aim of this study is to evaluate the efficacy and the safety of a food supplement containing myo-inositol in T2MD patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With diagnosis of Type 2 Mellitus Diabetes for at least 1 year
- •Levels of Hb1Ac ranging from 7.5% to 9.0%
排除标准
- •Patients that require insulin treatment
- •Treated at baseline with food supplements or drugs containing Myo-inositol, D-chiro-inositol, alphalactalbumin, zinc, or Gymnema Sylvestre;
- •Any contraindications to the treatment or to any substance used for the treatment
- •Subjects with intestinal malabsorption
- •Patients subjected to surgery within 6 months before baseline;
- •Chronic treatment with systemic corticosteroids
结局指标
主要结局
Glycated hemoglobin
时间窗: up to 6 months of treatment
Variation of glycated hemoglobin level (HbA1c) after 3 and 6 months in comparison to baseline detected in the blood - %
次要结局
- Hypoglycemic events(At baseline and 3 and 6 months of treatment)
- Glycemia(At baseline and 3 and 6 months of treatment)
- Cholesterol(At baseline and 3 and 6 months of treatment)