Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Reduction of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery
研究概览
简要总结
This study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).
详细描述
It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. Time monitoring of the patient after surgery is 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years (male or female).
- •BMI >35 kg/m2 who meet the following criteria:
- •GFR 30-60 ml/min and proteinuria>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
- •GFR >60 ml/min and proteinuria >(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
- •Patients with BMI> 40 kg/m2 with a GFR> 30 ml/min and proteinuria >(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
- •Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document.
排除标准
- •Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days.
- •Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation.
- •Patients with poorly controlled blood pressure (SBP> 170 mmHg or DBP> 110 mmHg).
- •Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months.
- •Patients treated with steroids or other immunosuppressants.
- •Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use.
- •Patients who are pregnant or lactating.
- •Patients who do not sign the informed consent.
- •A slight chance of compliance with visits scheduled in the protocol.
结局指标
主要结局
Reduction of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery
时间窗: 24 months
Reduction (measured as a percentage) of proteinuria/albuminuria in patients with obesity after bariatric surgery.
次要结局
未报告次要终点
研究者
Enrique Morales Ruiz, MD
Principal Investigator
Hospital Universitario 12 de Octubre