The Effect of Weight Loss Surgery on Preservation of Kidney Function and Cardiovascular Disease Risk Factors in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
研究概览
简要总结
Weight loss surgery is the most effective weight loss treatment available, but the direct effect on chronic kidney disease is less widely understood. Early research shows some improvement in kidney function may occur and candidacy for kidney transplantation can be improved with weight loss following surgery. To date, no randomised controlled trial has been performed to examine the effect of weight loss surgery on the progression of chronic kidney disease.
This randomised trial will allocate patients to either lifestyle modification with diet, exercise and pharmacotherapy, or weight loss surgery to remove two thirds of the stomach using the laparoscopic sleeve gastrectomy procedure. This study aims to evaluate weight loss surgery vs lifestyle modification in patients with chronic kidney disease with estimated kidney function of 20-60% and morbid obesity (BMI 35-45) in terms of kidney function, cardiovascular disease risk factors and all-cause mortality.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stages 3-4 CKD patients (GFR 20-60 mL/min)
- •Male or female
- •BMI 35-45 kg/m2
- •Aged >18 years
- •Previously attempted weight loss
- •Fit or anesthesia and surgery
- •Written informed consent
排除标准
- •Pregnancy
- •History of chronic liver disease
- •Previous gastric surgery or large hiatus hernia
- •Previous bariatric surgery
- •Psychiatric illness, including anxiety, mood and untreated eating disorders
- •Malnutrition (assessed by subjective global assessment)
- •Infection or course of antibiotics within the last month
- •Unwilling to consider surgical treatment
- •Previous kidney transplant
结局指标
主要结局
Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
时间窗: 0, 6, 12 months
次要结局
- Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)(0, 6, 12, 24, 36 months)
- Quality of life and anxiety and depression assessment(0, 6, 12, 24, 36 months)
- Urinary albumin to creatinine ratio and protein to creatinine ratio(0, 6, 12, 24, 36 months)
- Insulin resistance (HOMA method)(0, 6, 12 months)
- Endothelial function (flow mediated dilatation)(0, 6, 12 months)
- Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG(0, 6, 12 months)
- Body composition (weight, BMI, waist and hip circ, BIA)(0, 6, 12 months)
- Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a(0, 6, 12 months)