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

King's College Hospital NHS Trust

Status: Completed

Conditions: Chronic Kidney Disease; Obesity

Treatments: Behavioral: weight management program; Procedure: laparoscopic sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01053130

09/H0806/69 (Other Identifier)

KCH1639

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

weight loss surgery

Experimental group

Description:

laparoscopic sleeve gastrectomy

Treatment:

Procedure: laparoscopic sleeve gastrectomy

Lifestyle Intervention

Active Comparator group

Description:

Diet and exercise with or without pharmacotherapy

Treatment:

Behavioral: weight management program