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
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
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
NCT ID
NCT01053130
First Posted
January 20, 2010
Last Updated
June 8, 2016
Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
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
Learn more about this trial
Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial
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