Kidney Fat in Type 2 Diabetes & Diabetic Kidney Disease and the Effects of Ezetimibe: A Cross-Sectional Study and Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urinary albumin creatinine ratio (UACR)
研究概览
简要总结
In this study, we seek to explore the importance of fat accumulation in the kidneys in relation to diabetic kidney disease (DKD). To do this, we conduct an intervention trial in individuals with type 2 diabetes (T2D) and DKD where we investigate whether the inhibition of intestinal cholesterol absorption with ezetimibe affects albuminuria (a strong risk factor for diabetic complications) and kidney fat accumulation. At the same time and to confirm that kidney fat accumulation is, in fact, abnormal in T2D and DKD, we conduct a cross-sectional study in which we compare kidney fat accumulation in participants at baseline from the intervention trial with a group of individuals with T2D and no DKD and a group of healthy individuals.
详细描述
Objective:
- To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease.
- To assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.
Design:
- Cross-sectional study on 30 controls, 30 individuals with type 2 diabetes and no diabetic kidney disease and 60 individuals with type 2 diabetes and non-severe diabetic kidney disease.
- Single-center, randomized, double-blinded, placebo-controlled and parallel intervention trial in 60 individuals with type 2 diabetes and non-severe diabetic kidney disease Comparative treatment regime: Ezetimibe 10mg per day versus placebo for 16 weeks
Primary endpoint in cross-sectional study:
- Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To ensure blinding to the trial drug, the tablets containing either ezetimibe or placebo are incapsulated with gelatin and thus identical in appearance (size, color and shape).
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ezetimibe
One treatment period of 16 weeks with1 capsule of ezetimibe 10mg per day, as add-on to standard care.
干预措施: Ezetimibe 10mg (Drug)
Placebo
One treatment period of 16 weeks with 1 capsule of matching placebo per day, as add-on to standard care.
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary albumin creatinine ratio (UACR)
时间窗: Change over 16 weeks of treatment
次要结局
- Magnetic resonans estimate of kidney parenchymal triglyceride fraction(Change over 16 weeks of treatment)