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

Study Overview
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Brief 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.

Official Title
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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

Conditions
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Chronic Kidney Disease, Obesity

Intervention / Treatment
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* Procedure: laparoscopic sleeve gastrectomy
* Behavioral: weight management program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weight loss surgery<br>laparoscopic sleeve gastrectomy | Procedure: laparoscopic sleeve gastrectomy<br>* laparoscopic sleeve gastrectomy plus dietary and physical activity support<br>|
| Active Comparator: Lifestyle Intervention<br>Diet and exercise with or without pharmacotherapy | Behavioral: weight management program<br>* 1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body composition (weight, BMI, waist and hip circ, BIA) |  | 0, 6, 12 months | 
| Insulin resistance (HOMA method) |  | 0, 6, 12 months | 
| Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a |  | 0, 6, 12 months | 
| Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG |  | 0, 6, 12 months | 
| Endothelial function (flow mediated dilatation) |  | 0, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, bariatric surgery, chronic kidney disease, weight loss, exercise