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 |
| IRAS number | 247521 |
| Secondary identifying numbers | 19SM4996, CPMS 41656, IRAS 247521 |
- 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
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
Scientific
Imperial Clinical Trials Unit (ICTU)
Stadium House, 68 Wood Lane
London
W12 7RH
United Kingdom
| embio@imperial.ac.uk |
Study information
| Study design | Multi-centre double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Absolute difference in percent weight loss (in kg) measured using weighing scales between baseline weight and weight at 12 months post-treatment |
| Secondary outcome measures | 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? |
| Overall study start date | 02/08/2021 |
| Completion date | 09/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centres
Bariatric Clinic
London
W2 1NY
United Kingdom
Bariatric Clinic
235 Euston Road
London
NW1 2BU
United Kingdom
Sponsor information
University/education
Research Office, Room 221
St Mary's Campus
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)2033110212 |
|---|---|
| rgit@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Efficacy and Mechanism Evaluation Programme, EME
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The trial results will be presented at an international conference and published in a high impact peer-reviewed journal. No additional documents are available. |
| 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 28/09/2023 | 29/09/2023 | Yes | No |
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.
