Brief Summary

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Official Title: "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"

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
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: January 2012

Interventions Used in this Clinical Trial

• Procedure: laparoscopic sleeve gastrectomy
  • laparoscopic sleeve gastrectomy plus dietary and physical activity support
• Behavioral: weight management program
  • 1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: weight loss surgery
  • laparoscopic sleeve gastrectomy
• Active Comparator: Lifestyle Intervention
  • Diet and exercise with or without pharmacotherapy

Outcome Measures for this Clinical Trial

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
  • Time Frame: 0, 6, 12, 24, 36 months
    Safety Issue?: No
• Quality of life and anxiety and depression assessment
  • Time Frame: 0, 6, 12, 24, 36 months
    Safety Issue?: No
• Urinary albumin to creatinine ratio and protein to creatinine ratio
  • Time Frame: 0, 6, 12, 24, 36 months
    Safety Issue?: No
• Body composition (weight, BMI, waist and hip circ, BIA)
  • Time Frame: 0, 6, 12 months
    Safety Issue?: No
• Insulin resistance (HOMA method)
  • Time Frame: 0, 6, 12 months
    Safety Issue?: No
• Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
  • Time Frame: 0, 6, 12 months
    Safety Issue?: No
• Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
  • Time Frame: 0, 6, 12 months
    Safety Issue?: No
• Endothelial function (flow mediated dilatation)
  • Time Frame: 0, 6, 12 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • King's College Hospital NHS Trust
• Collaborator
  • King's College London
• Provider of Information About this Clinical Study
  • Miss Helen MacLaughlin, King's College Hospital NHS Foundation Trust
• Overall Contact(s)
  • Helen L MacLaughlin, BSc (Hons), + 44 20 7848 0431, helen.maclaughlin@kch.nhs.uk