Measurement of Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery in Kidney Patients With Severe Obesity or Massive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Ratio DFG / VEC
研究概览
简要总结
Obesity promotes chronic kidney disease and is accelerating its shift to the stage of renal replacement. Bariatric surgery is a treatment for severe or morbid obesity whose renal benefit is currently unknown. The glomerular filtration rate (GFR) is the best parameter to define the kidney function. It can be estimated using formulas by assaying endogenous markers (creatinine, cystatin C) or measured with an exogenous tracer glomerular filtration (51 Cr-EDTA).
Bariatric surgery alters the production of endogenous markers and the extracellular volume (VEC) with 2 important consequences on the assessment of GFR: the formula to estimate GFR is not possible to compare renal function before and after surgery because of the variation in production of endogenous glomerular filtration markers in the same subject; decreasing VEC predicted decreased GFR after surgery, since these parameters are in part proportional to each other.
Our working hypothesis is that bariatric surgery protects the kidneys of patients with chronic kidney disease. To demonstrate this, investigators propose to compare the ratio DFG / VEC before and after gastric bypass.
Goals The main objective is to measure the effect of gastric bypass on the report DFG / VEC. Secondary objectives are to assess the effect of gastric bypass on the albumin / urine creatinine and evaluate the performance of the main GFR estimating formulas in people with severe or morbid obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Topic GFR estimated by having the simplified formula of MDRD <60 ml / min / 1.73 m²
- •Topic with BMI ≥ 40 kg / m², or ≥ 35 kg / m²
- •Subject having at least one comorbidity could be improved after surgery after failure of medical treatment: hypertension , OSAHS and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes , debilitating musculoskeletal diseases, steatohepatitis nonalcoholic .
- •Topic who signed the informed consent
- •Topic affiliated to the social security
- •Male or female Topics
- •Elderly 18 to 70 inclusive
排除标准
- •Non- Caucasian person because the necessary correction factors and not always available for the formula to estimate GFR ( Cockcroft , Salazar and Corcoran ) .
- •No major under guardianship
- •Nobody hospitalized without his consent and not protected by law
- •Private person of liberty
- •Pregnant Woman, knowing that a pregnancy test will be performed for women of childbearing age . Results will be communicated to the patient by a doctor of his choice.
- •Rapidly progressive glomerulonephritis
- •Nephrotic proteinuria ranking
研究组 & 干预措施
DFG mesure
Measure the effect of gastric bypass on the report DFG / VEC
干预措施: DFG mesure (Other)
结局指标
主要结局
Ratio DFG / VEC
时间窗: Month 12
Average ratio DFG / VEC before and one year after gastric bypass
次要结局
- Albumin / urine creatinine(Month 12)
- GFR estimation formula(Month 12)