Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine; a Prospectivee, Randomized, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney failure,heart disease and premature death. Unfortunately, the best medical therapies available for DKD today are ultimately unable to prevent its progression, especially in obese patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB), improves diabetes and some of its complications.
The investigators propose to investigate whether RYGB in combination with best medical therapy in patients with DKD and obesity prevent further deterioration of kidney function over a 3 years follow up period.
Study design: This is an international collaboration with leading centres in Sweden and Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to be randomly assigned to receive best medical therapy with RYGB or best medical therapy without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney function. Yearly measurements of kidney function will then be done over a period of 3 years as a primary outcome to determine whether differences in DKD can be detectable. The study will also examine and compare a) safety of the interventions, b) the health economic impact on direct healthcare costs and Quality of Life in patients as well as c) the value of a new marker of DKD in determining which patients are most likely to benefit from surgery.
Overall the study will strengthen the evidence base guiding clinical decisions about the usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD in patients with obesity and diabetes.
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
- •• BMI 28 - 35 kg/m2
- •Age: 18-65 years, with T2DM
- •Estimated glomerular filtration rate (eGFR; by MDRD) between 30 and 60mL/min/1.73m2
- •Urine albumin creatinine ratio (ACR) of at least 30mg/g (microalbuminuria) in first void urine on two separate days.
排除标准
- •• Type 1 diabetes or a positive GAD antibody test
- •Known renal artery stenosis
- •Renal impairment for reasons unrelated to diabetes
- •Suspicion of glomerulonephritis as determined by urine sediment (>10 erythrocytes/visual field)
- •Post-renal obstruction diagnosed by ultrasound
- •Severe retinopathy (defined as high-risk proliferative diabetic retinopathy and severe visual loss according to the "Early Treatment Diabetic Retinopathy Study Severity Scale")
- •Severe DKD (CKD 4 or 5, requirement of renal replacement therapy such as dialysis or kidney transplantation)
- •Severe neuropathy (peripheral neuropathy stage 3)
- •Unacceptably high risk for general anesthesia
- •Prior extensive intra-abdominal surgery making laparoscopy complicated
- •Myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary-artery bypass grafting or percutaneous transluminal coronary angioplasty within the previous 6 months
- •Cardiac failure (NYHA stage > 2)
- •Inability to stop smoking prior to inclusion
- •Pregnancy or breast feeding
结局指标
主要结局
Glomerular filtration rate
时间窗: Three years after intervention
Renal function measurement by Iohexol clearance
次要结局
- Microvascular kidney damage(3 years after intervention)
- Glycaemic control(3 years after intervention)
- peripheral nervous system function(3 years after intervention)
- autonomic nervous system function(3 years after intervention)
- diabetic eyes complications(3 years after intervention)
- blood preassure(3 years after intervention)
- Lipids(3 years after intervention)
研究者
Anders Thorell
Professor
Karolinska Institutet