Clinical trial NCT01053130: Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Obesity
Keywords: obesity
bariatric surgery
chronic kidney disease
weight loss
exercise
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2010-01-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
timeFrame: 0, 6, 12 months
Secondary outcomes:
measure: Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
timeFrame: 0, 6, 12, 24, 36 months
measure: Quality of life and anxiety and depression assessment
timeFrame: 0, 6, 12, 24, 36 months
measure: Urinary albumin to creatinine ratio and protein to creatinine ratio
timeFrame: 0, 6, 12, 24, 36 months
measure: Body composition (weight, BMI, waist and hip circ, BIA)
timeFrame: 0, 6, 12 months
measure: Insulin resistance (HOMA method)
timeFrame: 0, 6, 12 months
measure: Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
timeFrame: 0, 6, 12 months
measure: Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
timeFrame: 0, 6, 12 months
measure: Endothelial function (flow mediated dilatation)
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References:
citation: Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.