Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • 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

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

Clinical Trial Outcome Measures

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

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
  • 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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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

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