Condition category
Urological and Genital Diseases
Date applied
21/06/2011
Date assigned
21/06/2011
Last edited
18/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helen MacLaughlin

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

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

http://www.kcl.ac.uk/index.aspx

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

Publication citations

Additional files

Editorial Notes

18/12/2015: Publication reference added.