The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage change of 24-hour proteinuria
研究概览
简要总结
The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight reduction. The investigators hypothesized that benefits of weight loss may reduce proteinuria.
详细描述
This is a prospective randomized study in adult IgA nephropathy. The investigators enrolled 30 patients who have proteinuria exceeds 1 g per day with biopsy proven IgA nephropathy. The experimental arm recieves the non-pharmacological treatment, weight reduction protocol. All patients in this arm must be reduce their body weight in 3-5 % from baseline as protocol. Another arm is control group which recieves standard treatment of IgA nephropathy including ACEIs/ARBs for blood pressure control (target < 130/80 mmHg). The primary outcome is proteinuria level. The secondary outcome is cytokines and inflammatory markers level including interleukin-6, resistin, adiponectin, leptin and monocyte chemoattractant protein-1.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven IgA nephropathy
- •body mass index more than 23 Kg/m2
- •24 hours urine protein more than 1 g
- •estimated GFR more than 20 ml/min
排除标准
- •pregnancy and lactation
- •rapidly renal function decline
- •crescent formation in renal biopsy more than 10%
结局指标
主要结局
Percentage change of 24-hour proteinuria
时间窗: 6 months
The investigators measure amount of 24-hour proteinuria at randomization peroid ( as baseline), first, third and sixth month. Then, investigators calculate the percentage reduction of proteinuria at different time points.
次要结局
- plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1(6 months)
研究者
Talerngsak Kanjanabuch
Kidney and metabolic research center, Faculty of medicine
Chulalongkorn University