Effect of Bariatric Surgery on Kidney Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in accurately measured GFR
研究概览
简要总结
Primary hypothesis:
A large reduction in weight is not associated with a change in accurately measured glomerular filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance (51Cr-EDTA)).
Secondary hypothesis:
A large reduction in weight is associated with a greater change in estimated GFR (The Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.
Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately measured GFR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, older than 18 years of age
- •Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark
排除标准
- •Withdrawal of surgical indication
- •Severe oedema or ascites
研究组 & 干预措施
Bariatric surgery
干预措施: Gastric by-pass surgery (Procedure)
结局指标
主要结局
Change in accurately measured GFR
时间窗: Up to 6 months and 18 months after surgery
次要结局
- Change in body composition, as measured by Dual-energy X-ray absorptiometry scan (DXA-scan)(Up to 6 months and 18 months after surgery)
- Change in accurately measured GFR compared with change in estimated GFR(Up to 6 months and 18 months after surgery)
- Change in 24hour blood pressure(Up to 6 months and 18 months after surgery)
- Change in estimated GFR (as measured by the MDRD formula, the Cockcroft Gault formula, CKD-EPI formula and CKD-EPI with cystatin C formula).(Up to 6 months and 18 months after surgery)
- Change in arterial stiffness (as measured by sphygmocor)(Up to 6 months and 18 months after surgery)
研究者
Peter Rossing
Professor
Steno Diabetes Center Copenhagen