Chronic Kidney Disease, Obesity
Conditions
Keywords
obesity, bariatric surgery, chronic kidney disease, weight loss, exercise
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.
Interventions
PROCEDURElaparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy plus dietary and physical activity support
BEHAVIORALweight management program
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months
Sponsors
King's College London
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation) | 0, 6, 12, 24, 36 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 |
| Insulin resistance (HOMA method) | 0, 6, 12 months |
Countries
United Kingdom
Outcome results
None listed