REVISE-Diabesity: Randomisation to Endobarrier alone Versus with Incretin analogue in SustainEd Diabesity

Plain English Summary

Background and study aims
Effective treatment options for combined diabetes and obesity, sometimes called diabesity, are fairly limited. There are diet and exercise lifestyle options, oral and injectable medications including insulin and Liraglutide (Victoza). Despite current treatment options, diabetes and weight often remain uncontrolled with high blood sugars and obesity. Surgery to reduce stomach size or bypass the intestine may be considered radical. The aim of this study is to find out if a new device called the Endobarrier is an effective treatment option for diabesity either alone or in combination with diabetes medications. We are also seeking to find out how the device works in reducing weight and improving diabetes control.

Who can participate?
Adult patients with type 2 diabetes and obesity can take part if they have tried at least 6 months' treatment with Liraglutide. Participants should be able to attend their local study centre (King's College Hospital, London; Guy's and St Thomas' Hospitals, London; City Hospital, Birmingham, Glasgow Royal Infirmary), so distance from these centres is a factor which may affect participation.

What does the study involve?
Participants will be randomly allocated to one of the following three treatments:
1. Endobarrier alone: Endobarrier implanted for 1 year, inserted and removed by endoscopic procedure. Liraglutide stopped for 2 years.
2. Endobarrier + Liraglutide: Endobarrier implanted for 1 year, inserted and removed by endoscopic procedure. Liraglutide continued for 2 years.
3. Liraglutide alone.
The hospital visits will take place at: City Hospital, Birmingham, King's College Hospital, London or Glasgow Royal Infirmary for routine diabetes care including checks of weight, body mass index, and blood tests. Additional tests will include blood tests, a telephone interview of dietary habits, and stool and urine tests that will be done to better determine how the device works. All patients will be asked to follow a standard diet (liquid/puree food) for the first 2 weeks written in a dietary information sheet that we will provide. For patients in the Endobarrier treatment groups, they will fast on the day preceding the insertion, which will be done under general anaesthetic. During the procedure, the endoscopy doctor will gently pass an endoscope (a flexible telescope with a light at the end) through the patient's mouth until it is just beyond the stomach. X-rays will also be used to ensure the Endobarrier's position.

What are the possible benefits and risks of participating?
The possible benefits of taking part include an improvement in diabetes and reduction in weight in all treatment groups. It is possible that these benefits may be considerable. However, this cannot be guaranteed. The information we get from this study may help us to treat future patients with diabesity better. There are risks that the device may fail, move, become blocked, block the intestine, or cause bleeding or pain. The overall risk for this is low (<5%). If this occurs, another endoscopic procedure will be required to remove the device. Bleeding or perforation complications will usually become evident within a few hours of the procedure (abdominal pain) so patients will be observed following the procedure. If there is severe pain, bleeding or black tarry stool in the days following the procedure, the Emergency Department should be contacted (and inform the research team but this should not delay you attending the Emergency Department). It is possible that if the treatment is given to a pregnant woman it will harm the unborn child. Pregnant women must not therefore take part in this study, neither should women who plan to become pregnant during the study. Women who are at risk of pregnancy may be asked to have a pregnancy test before taking part to exclude the possibility of pregnancy. Women who could become pregnant must use an effective contraceptive during the course of this study. Any woman who becomes pregnant during the study should immediately tell her research doctor. In this trial, x-rays will be used to guide the Endobarrier device into place and check its position after insertion. We are all exposed to a background level of radiation from natural and artificial sources; the radiation received as part of this trial is equivalent to about 3 years' worth of this background radiation. It is similar to the maximum dose that someone working with radiation is allowed to receive each year. There is a small risk to patients from this radiation: the likelihood of detrimental effects is estimated to be 1 in 2,500. This small risk is considered to be acceptable when compared with the potential benefits from having the device fitted.

Where is the study run from?
The lead site is City Hospital, Birmingham (the sponsor is Sandwell and West Birmingham Hospitals NHS Trust, which is organising and overseeing it). Other locations are London and Glasgow.

When is the study starting and how long is it expected to run for?
The study began recruiting patients in June 2013 and the first study-related Endobarrier
insertion procedure was done in July 2013. The study is expected to finish in November 2015.

Who is funding the study?
The research is funded by the Association of British Clinical Diabetologists (ABCD). The research team is not funded by the device manufacturers.

Who is the main contact?
Dr Piya Sen Gupta - Research Fellow
piya.sengupta@nhs.net

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Sandwell and West Birmingham Hospitals NHS Trust (UK)
Hospital/treatment centre

Lyndon
West Bromwich
B71 4HJ
England
United Kingdom

Email	swbh.randd@nhs.net
Website	https://www.swbh.nhs.uk/
"ROR"	https://ror.org/05mzf3276

Funders

Funder type

Research council

Results and Publications

Study outputs

Editorial Notes

21/05/2019: No publications found, verifying study status with principal investigator.
13/04/2018: Publication and dissemination plan updated.

The registration was initiated on 07/03/2013 and finalised on 31/07/2013. The recruitment started on 10/06/2013, after initiation of public registration.