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

Primary Purpose

Chronic Kidney Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy
weight management program
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring obesity, bariatric surgery, chronic kidney disease, weight loss, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

weight loss surgery

Lifestyle Intervention

Arm Description

laparoscopic sleeve gastrectomy

Diet and exercise with or without pharmacotherapy

Outcomes

Primary Outcome Measures

Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease

Secondary Outcome Measures

Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
Quality of life and anxiety and depression assessment
Urinary albumin to creatinine ratio and protein to creatinine ratio
Body composition (weight, BMI, waist and hip circ, BIA)
Insulin resistance (HOMA method)
Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
Endothelial function (flow mediated dilatation)

Full Information

First Posted
January 20, 2010
Last Updated
June 8, 2016
Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT01053130
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Obesity
Keywords
obesity, bariatric surgery, chronic kidney disease, weight loss, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weight loss surgery
Arm Type
Experimental
Arm Description
laparoscopic sleeve gastrectomy
Arm Title
Lifestyle Intervention
Arm Type
Active Comparator
Arm Description
Diet and exercise with or without pharmacotherapy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Intervention Description
laparoscopic sleeve gastrectomy plus dietary and physical activity support
Intervention Type
Behavioral
Intervention Name(s)
weight management program
Intervention Description
1200-1500 kcal renal diet, increased physical activity, with optional orlistat therapy at 120 mg tds for 12 months
Primary Outcome Measure Information:
Title
Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease
Time Frame
0, 6, 12 months
Secondary Outcome Measure Information:
Title
Composite end point of death and cardiovascular outcomes (stroke, myocardial infarction or congestive heart failure hospitalisation)
Time Frame
0, 6, 12, 24, 36 months
Title
Quality of life and anxiety and depression assessment
Time Frame
0, 6, 12, 24, 36 months
Title
Urinary albumin to creatinine ratio and protein to creatinine ratio
Time Frame
0, 6, 12, 24, 36 months
Title
Body composition (weight, BMI, waist and hip circ, BIA)
Time Frame
0, 6, 12 months
Title
Insulin resistance (HOMA method)
Time Frame
0, 6, 12 months
Title
Serum adiponectin, leptin, IL-6, TNF-α, hs-CRP, fetuin a
Time Frame
0, 6, 12 months
Title
Urinary markers IL-6, MCP-1, IL-1β, RBP, NAG
Time Frame
0, 6, 12 months
Title
Endothelial function (flow mediated dilatation)
Time Frame
0, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33782940
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.
Results Reference
derived

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

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