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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Chronic Kidney Disease
  • Obesity
Helen L MacLaughlin, BSc (Hons)
+ 44 20 7848 0431
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01053130
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Procedure : laparoscopic sleeve gastrectomy, Behavioral : weight management program

Study Arm Groups : weight loss surgery, Lifestyle Intervention

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
60
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
King's College Hospital
London
England
SE5 9RS
Trial Contact(s)
Primary Trial Contact
Helen L MacLaughlin, BSc (Hons)
helen.maclaughlin@kch.nhs.uk
+ 44 20 7848 0431
Other Trial Contacts
Iain C Macdougall, MD FRCP
iain.macdougall@kch.nhs.uk
6940 + 44 20 3299 9000
Countries Recruiting
United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • King's College London
Other Study ID Numbers
KCH1639
Sponsor(s)
King's College Hospital NHS Trust
Key Dates

Recruitment Start Date

Jan 2010

Recruitment End Date

Jan 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

20 Jan 2010

Last Updated

20 Jan 2010