Can restricting the blood supply to part of the stomach lead to weight loss in severely overweight patients?

ISRCTN	ISRCTN16158402
DOI	https://doi.org/10.1186/ISRCTN16158402
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	247521
Protocol serial number	19SM4996, CPMS 41656, IRAS 247521
Sponsor	Imperial College London
Funder	Efficacy and Mechanism Evaluation Programme

Submission date: 25/08/2021
Registration date: 27/09/2021
Last edited: 27/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Recently some studies in animals have shown that if the blood supply to a specific area of the stomach is reduced (the stomach fundus or the top of the stomach), the stomach reduces the production of a hormone called ghrelin. This hormone is the only hormone known to cause an increase in appetite. One of the ways to reduce the blood supply to the stomach fundus is by a procedure called catheter embolisation. This is very similar to other catheter angiograms such as leg or heart angiograms. It can be done painlessly under local anaesthetic in the x-ray room within the hospital and takes usually less than 1 hour to perform. The participants would need to stay in hospital for 2 hours afterwards for observation. Although this procedure has not been done before for weight loss specifically, it is very often done for other conditions like bleeding stomach ulcers and has been shown to be safe in these situations. Indeed some researchers have found that patients having stomach embolisations for bleeding stomach ulcers lost more weight than patients having embolisations to other organs or other areas of the stomach. The aim of this study is to find out whether this could be an effective and safe technique to help with weight loss.

Who can participate?
Patients aged 18 years or older with a body mass index (BMI) between 35 and 50 kg/m², living within 25 miles of the enrolling institution and able to lie face up

What does the study involve?
Participants are randomly allocated to undergo either embolisation or a "sham" procedure. A sham procedure involves a small needle into the wrist under local anaesthetic, but not proceeding any further. The study also involves dietary and exercise advice under the supervision of a specialist dietician and an obesity medicine physician, and routine investigations of blood pressure, blood tests to look at stomach hormones and blood sugar levels, and a simple test to look at the stomach lining (endoscopy) and also at how the stomach empties. The participants are followed up on a regular basis for 12 months. The researchers hope to show that this procedure is effective at reducing weight and improving obesity-related comorbidities.

What are the possible benefits and risks of participating?
There is a possibility that participants will be able to lose weight due to the intervention. There is also a possibility that because of the procedure or medical care, other conditions related to obesity will become less severe or disappear. No serious risks or side effects have been reported with catheter embolisation. To date, only five gastric erosions have been reported (damage to the stomach lining healing within 30-90 days), and one case (out of 65) of pancreatitis (inflammation of the pancreas). Complications during catheter insertion through the artery in the wrist or groin are rare. The risk of a complication occurring is estimated to be less than 1 in 1,000 during every procedure. Complications include artery blocking and local bruising (haematoma). There is a 1-3% (1-3 in 100) risk of bleeding or infection when inserting a catheter through the artery in the wrist or groin.

Where is the study run from?
Imperial College London (UK)

When is the study starting and how long is it expected to run for?
August 2021 to July 2024

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Claire Smith, embio@imperial.ac.uk

Contact information

Dr Claire Smith
Scientific

Imperial Clinical Trials Unit (ICTU)
Stadium House, 68 Wood Lane
London
W12 7RH
United Kingdom

Email	embio@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre double-blinded randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Left gastric artery embolisation for weight loss in obese patients with BMI 35-50 kg/m²: the EMBIO trial
Study acronym	EMBIO
Study objectives	To evaluate the efficacy of left gastric artery embolisation (LGAE) on weight loss and obesity-related comorbidities at pre-determined times points over a 12-month follow-up period.
Ethics approval(s)	Approved 11/10/2019, London - Central Research Ethics Committee (Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0) 207 104 8007; NRESCommittee.London-Central@nhs.net), REC ref: 19/LO/0509
Health condition(s) or problem(s) studied	Obesity
Intervention	The trial interventionist will randomise the patient to either left gastric artery embolisation (LGAE) or a placebo procedure 1 to 1 using the online OpenClinica database. All participants will follow the hospital’s standard tier 3 clinical lifestyle program for weight loss from the time of the intervention up to 12 months.
Intervention type	Device
Phase	Phase II
Drug / device / biological / vaccine name(s)	-
Primary outcome measure(s)	Absolute difference in percent weight loss (in kg) measured using weighing scales between baseline weight and weight at 12 months post-treatment
Key secondary outcome measure(s)	1. Absolute difference in percent weight loss (in kg) measured using weighing scales between baseline weight and weight at 3 and 6 months 2. Total body loss (TBL) i.e. the absolute change in weight (in kg) measured using weighing scales from baseline to 12 months 3. Proportion of patients in each arm with ≥5% TBL measured using weighing scales at 12 months 4. Gut hormones (e.g. blood test for ghrelin, PYY, GLP-1) measured at baseline, month 3, month 6 and month 12 5. Hunger and satiety scores obtained using Visual Analogue Scales at baseline, month 3, month 6 and month 12 6. Food intake measured using meal test and food diaries at baseline, month 3, month 6 and month 12 7. Delay in gastric emptying measured using paracetamol test using participants plasma sample measured at baseline, month 3, month 6 and month 12 8. Eating behaviour and quality of life measured using questionnaires (SF36-V2, IQWOL lite, HADS, DEBQ, EPIC FFQ) at baseline, month 3, month 6 and month 12 9. Markers of obesity-related complications measured by blood tests for HbA1c, fasting glucose, insulin and blood pressure recording at baseline, month 3, month 6 and month 12 10. Frequency of adverse events based on the clinical judgement of the investigator at month 3, month 6 and month 12 11. Preference of treatment arm recorded by asking the participant to indicate their treatment arm preference meaning that they will need to answer the following question during visits at months 3, 6 and 12: ‘Knowing what has happened now - would you have chosen the same procedure?
Completion date	09/07/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	76
Key inclusion criteria	1. Adults aged 18-70 years 2. BMI 35-50 kg/m² 3. Ability to lie supine 4. Appropriate anatomy of the left gastric artery and coeliac plexus on CT angiogram 5. Willing and able to provide informed consent
Key exclusion criteria	1. Haematological, hepatic or renal dysfunction 2. Weight >150 kg 3. HbA1c >8.5% 4. Known renal, vascular or aortic disease 5. Malignancy 6. Prior major abdominal surgery, prior gastric or bariatric surgery 7. Prior abdominal radiotherapy 8. Gastrointestinal (GI) bleeding or bleeding diathesis 9. Allergy to iodinated contrast, 10. Known gastric ulceration or active H. pylori infection 11. Positive pregnancy test in females of childbearing age 12. Chronic Non-steroidal anti-inflammatory drug (NSAID) use 13. Current use of insulin or sulphonylurea 14. Current use of anti-tricyclic anti-depressants or steroids
Date of first enrolment	14/03/2022
Date of final enrolment	20/07/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

St Mary's Hospital

Imperial College Healthcare NHS Trust
Bariatric Clinic
London
W2 1NY
United Kingdom

University College Hospital

University College London Hospitals NHS Foundation Trust
Bariatric Clinic
235 Euston Road
London
NW1 2BU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		28/09/2023	29/09/2023	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/02/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2023 to 20/07/2023.
2. The overall study end date was changed from 31/07/2024 to 09/07/2024.
3. The intention to publish date was changed from 01/09/2024 to 01/06/2025.
4. Contact details updated.
29/09/2023: Publication reference added.
07/02/2022: The recruitment start date has been changed from 28/02/2022 to 14/03/2022.
10/01/2022: The recruitment start date was changed from 17/01/2022 to 28/02/2022.
14/12/2021: The recruitment start date was changed from 01/12/2021 to 17/01/2022.
01/10/2021: Internal review.
28/09/2021: Internal review.
27/08/2021: Trial's existence confirmed by London - Central Research Ethics Committee.