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

Sponsor

King's College Hospital NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01053130

Collaborator

King's College London (Other)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Obesity	Procedure: laparoscopic sleeve gastrectomy Behavioral: weight management program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: weight loss surgery

laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

laparoscopic sleeve gastrectomy plus dietary and physical activity support

Active Comparator: Lifestyle Intervention

Diet and exercise with or without pharmacotherapy

Behavioral: weight management program

1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months

Outcome Measures

Primary Outcome Measures

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

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]