Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10025
Study information
Scientific title
A prospective cohort study of laparoscopic sleeve gastrectomy for weight loss in obese patients on haemodialysis: proof of concept
Acronym
Study hypothesis
Obesity can cause chronic kidney disease and lead to kidney failure. However, obese patients are less likely to be eligible for kidney transplantation - the best treatment option for patients with kidney failure. Weight loss surgery is an effective treatment for weight loss but has not yet been studied systematically in patients with kidney failure.
This research aims to find out whether weight loss surgery is an effective and safe treatment for obesity in patients with kidney failure on haemodialysis.
Ethics approval
10/H0716/55
Study design
Non-randomised, interventional, treatment
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Renal and Urogenital
Intervention
1. 15 volunteer haemodialysis patients with a body mass index > 35 will have keyhole surgery to reduce the size of their stomach to limit food intake and hunger. 2. The weight loss surgery procedure selected is the sleeve gastrectomy
3. In this operation, the size of the stomach is permanently reduced to one-third of its original size by removing some of the stomach to form a smaller, tube shaped stomach.
4. Another 15 patients with a body mass index >35 who choose not to have keyhole surgery will also be studied as a comparison group
5. Weight loss, achieving the body mass index criteria for listing for kidney transplantation, quality of life, changes in blood pressure and blood fats and the safety of the operation will be measured over 1 year
Intervention type
Drug
Phase
Not Applicable
Drug names
Orlistat
Primary outcome measures
1. BMI <35 kg/m2
2. Measured at timepoint(s) of 6 and 12 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
07/02/2011
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. On haemodialysis for at least 90 days
2. Male or female, aged > 18 years
3. BMI > 35 kg/m2
4. Previously attempted weight loss (surgery arm only)
5. Fit for anesthesia and surgery (surgery arm only)
6. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Pregnancy
2. History of chronic liver disease
3. Previous bariatric surgery, gastric surgery or large hiatus hernia
4.Psychiatric illness, including anxiety, mood and untreated eating disorders
5. Malnutrition (assessed by subjective global assessment)
6. Infection or course of antibiotics within the last month
7. Peritoneal dialysis
Recruitment start date
07/02/2011
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
Kings College London
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Renal Society
Alternative name(s)
BRS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/21611875