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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Obesity
• Interventions: Procedure: laparoscopic sleeve gastrectomy; Behavioral: weight management program

• Registration Number: NCT01053130
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
weight loss surgery	laparoscopic sleeve gastrectomy	laparoscopic sleeve gastrectomy
Lifestyle Intervention	weight management program	Diet and exercise with or without pharmacotherapy

Primary Outcome Measures

Name	Time	Method
Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease	0, 6, 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom