IRCT20161022030424N6招募中3 期
Investigation the effect of Probiotic supplement vs Placebo on anthropometric indices, quality of life, body composition, blood pressure, lipid profile and serum levels of adipokines and atherosclerosis dependent indices in elderlies with type 2 diabetes and high cardiovascular risk
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 no limit（—）
- 性别
- All
入选标准
- •> 65 years old
- •Diagnosed as having T2DM based on the criterion of the American Diabetes Association
- •At least moderately controlled diabetes (HbA1c<8.5%)
- •A stable anti-diabetic drug regimen (over 4 months) before starting the study
- •Body mass index <45 kg/m2
- •High risk of cardiovascular events: Albuminuria in two of three random urine samples in the last 24 hours and a positive history of macrovascular events
排除标准
- •Consumption of other Probiotic supplements and food products during the study
- •Multivitamin-mineral supplements or medicinal products that interfere with patients' anthropometric indices, blood pressure, lipid profile, and serum levels of adipokines and atherosclerosis dependent indices
- •Cancer and any chronic disease other than diabetes
- •Uncontrolled blood pressure
- •Uncontrolled severe diabetes
- •Acute gastrointestinal problem
- •Consumption of antibiotics during the study
- •Unusual stressful event during the study
研究者
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