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

Obesity Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053130
• Other study ID #: KCH1639
• Secondary ID: 09/H0806/69
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: June 8, 2016
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2010
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic
• Weight Loss

Intervention

Procedure:
• laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy plus dietary and physical activity support

Behavioral:
• weight management program
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease		0, 6, 12 months	No
Secondary	Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)		0, 6, 12, 24, 36 months	No
Secondary	Quality of life and anxiety and depression assessment		0, 6, 12, 24, 36 months	No
Secondary	Urinary albumin to creatinine ratio and protein to creatinine ratio		0, 6, 12, 24, 36 months	No
Secondary	Body composition (weight, BMI, waist and hip circ, BIA)		0, 6, 12 months	No
Secondary	Insulin resistance (HOMA method)		0, 6, 12 months	No
Secondary	Serum adiponectin, leptin, IL-6, TNF-a, hs-CRP, fetuin a		0, 6, 12 months	No
Secondary	Urinary markers IL-6, MCP-1, IL-1ß, RBP, NAG		0, 6, 12 months	No
Secondary	Endothelial function (flow mediated dilatation)		0, 6, 12 months	No