NCT03568409已完成不适用
Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
研究概览
简要总结
Evaluation of the improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with diagnosis of type 2 diabetes, aged 18-75
- •HbA1c at screening between 6.5% and 7.5%
- •Last 2 HbA1c values in the last 12 months between 6.5% and 7.5%
- •Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents
- •BMI 25-38 kg/m2
- •Willing and able to understand and sign the informed consent and complete the patient diary provided
- •Women participant of childbearing age should be negative to pregnancy test (performed on blood), and will have to use an appropriate contraceptive method throughout the study.
排除标准
- •Micro and macrovascular complication of diabetes in advanced stage (i.e., proliferative diabetic retinopathy; chronic renal failure III-IV stage KDOQI)
- •Chronic gastro-intestinal disease
- •Heavy smoker subjects
- •Alcohol abuse
- •Chronic liver and kidney disease (AST or ALT values > 2.5 UNL or plasma creatinine > 1.5 mg/dl)
- •Previous major gastrointestinal surgery
- •History of eating disorders
- •Pregnancy or lactation
- •Use of food supplements containing in particular but not limited to fibers and polysaccharides, in the last six months with frequency and dosage such as to interfere with the study.
- •Autoimmune diseases
- •Known hypersensitivity to any of the components of the product.
- •Any condition which prevent subject participation in the opinion of the principal investigator.
研究组 & 干预措施
Group A: ABO-GLYC
Experimental
Libramed
干预措施: ABO-GLYC (Device)
Group B: Placebo
Placebo Comparator
干预措施: ABO-GLYC Placebo (Other)
结局指标
主要结局
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
时间窗: Week0 and Week24
HbA1c measure
次要结局
- Improvement of markers of glycemic variability (HBGl)(Week0 to Week24)
- Improvement of markers of glyco-oxidative stress(Week0 to Week24)
- Improvement in markers of insulin secretion after standardized meal.(Week 0 and Week 24)
- Improvement of markers of glycemic variability (MAGE)(Week0 to Week24)
- Improvement of markers of glycemic variability (LBGI)(Week0 to Week24)
- Improvement of markers of metabolic status (BMI)(Week0 to Week24)
- Evaluation of gut microbiome changes (bacteria population)(Week 0, Week 1, Week 12, Week 24)
- Improvement of markers of glycemic variability (plasma glucose level)(Week0 to Week24)
- Improvement of markers of glycemic variability (hypo/hyper glycemia)(Week0 to Week24)
- Improvement of markers of inflammation(Week0 to Week24)
- Improvement of markers of metabolic status (lipid profile)(Week0 to Week24)
- Improvement of markers of metabolic status (body composition)(Week0 to Week24)
- Control of the glycemia.(Week0 to Week24)
- Evaluation of gut microbiome changes (SCFA)(Week 0, Week 1, Week 12, Week 24)
- Improvement in markers of insulin resistance(Week 0 and Week 24)
- Evaluation of the dietary adherence(Week0 to Week24)
- Adverse events (AEs) evaluation and product tolerability.(Week0 to Week24)
研究者
研究点 (1)
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