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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
laparoscopic sleeve gastrectomy plus dietary and physical activity support
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months
King's College Hospital
London, United Kingdom
Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
Time frame: 0, 6, 12 months
Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
Time frame: 0, 6, 12, 24, 36 months
Quality of life and anxiety and depression assessment
Time frame: 0, 6, 12, 24, 36 months
Urinary albumin to creatinine ratio and protein to creatinine ratio
Time frame: 0, 6, 12, 24, 36 months
Body composition (weight, BMI, waist and hip circ, BIA)
Time frame: 0, 6, 12 months
Insulin resistance (HOMA method)
Time frame: 0, 6, 12 months
Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
Time frame: 0, 6, 12 months
Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
Time frame: 0, 6, 12 months
Endothelial function (flow mediated dilatation)
Time frame: 0, 6, 12 months
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