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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease
- Sponsor
- King's College Hospital NHS Trust
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)