A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- efficacy of DCI oral supplementation on metabolic control
研究概览
简要总结
The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral supplementation in addiction to folic acid compared to folic acid alone on glycaemic control as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin therapy.
A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50 years (13 males, 13 females), with disease duration > 1 year and BMI >25, attending as outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome
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
- 17 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D patients
- •aged 17-50 years
- •disease duration > 1 year
排除标准
- •learning disabilities
- •presence of chronic conditions potentially able to influence daily activities (visual or auditory disability, motor impairment for neurological or orthopaedic problems).
- •T1D patients affected from diabetic complications
- •pregnancy
结局指标
主要结局
efficacy of DCI oral supplementation on metabolic control
时间窗: 6 months
efficacy of DCI oral supplementation on metabolic control as assessed by HbA1c (%)
次要结局
- BMI kg/m2(6 months)
- Insulin Requirement (I.R.) IU/kg(6 months)
研究者
Professor Paolo Pozzilli
Prof
Campus Bio-Medico University