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Health Condition(s) or Problem
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Chronic Kidney Disease; Obesity
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Procedure; laparoscopic sleeve gastrectomy; laparoscopic sleeve gastrectomy plus dietary and physical activity support; weight loss surgery; Behavioral; weight management program; 1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months; Lifestyle Intervention
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Primary aim
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Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
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Secondary Aim
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Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation); 0, 6, 12, 24, 36 months; No; Quality of life and anxiety and depression assessment; 0, 6, 12, 24, 36 months; No; Urinary albumin to creatinine ratio and protein to creatinine ratio; 0, 6, 12, 24, 36 months; No; Body composition (weight, BMI, waist and hip circ, BIA); 0, 6, 12 months; No; Insulin resistance (HOMA method); 0, 6, 12 months; No; Serum adiponectin, leptin, IL-6, TNF-a, hs-CRP, fetuin a; 0, 6, 12 months; No; Urinary markers IL-6, MCP-1, IL-1ß, RBP, NAG; 0, 6, 12 months; No; Endothelial function (flow mediated dilatation); 0, 6, 12 months; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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