CompletedPhase IIInterventional

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

This clinical trial is testing a new, non-surgical procedure to help adults living with severe obesity lose weight. The treatment works by gently reducing the blood flow to the top part of the stomach. Doctors do this using a thin, flexible tube called a catheter, inserted into a blood vessel under local anaesthetic. Previous medical evidence shows that reducing blood flow to this area lowers levels of ghrelin, a natural hormone that triggers hunger. In this study, participants are randomly chosen to have either the genuine procedure or a 'sham' (pretend) procedure. Everyone taking part receives 12 months of expert diet and exercise advice from specialist dietitians and doctors. The researchers want to find out if this technique is safe, helps people feel less hungry, and leads to meaningful weight loss and better health.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Imperial College London

Enrolment target

Start

14 Mar 2022

Estimated completion

20 Jul 2023

Obesity

What is this study about?

Living with obesity can make losing weight very difficult, even when trying hard to eat well and stay active. The human body naturally makes hormones that stimulate appetite. One key hormone is called ghrelin, often known as the 'hunger hormone', which is mostly produced in the upper section of the stomach. When ghrelin levels are high, your brain receives strong signals telling you to eat.

Doctors previously discovered that when patients had blood vessels in the stomach safely blocked to stop bleeding ulcers, many of them lost a noticeable amount of weight afterwards. The EMBIO trial is investigating whether deliberately reducing the blood supply to the top of the stomach can safely lower ghrelin levels and help people feel full sooner.

During the procedure, a doctor guides a tiny tube through a blood vessel in your wrist or groin to reach the stomach's blood supply. Tiny beads are released to slow the blood flow. It takes under an hour, is done while you are awake using local numbing medicine, and does not involve major surgery.

If the study proves successful, it could provide a simpler, less invasive option for people struggling to lose weight, helping to protect against related conditions such as type 2 diabetes and high blood pressure.

Key takeaways

Tests a simple, non-surgical procedure to reduce hunger hormones by gently blocking blood flow to part of the stomach.
Open to adults aged 18 to 70 with a BMI between 35 and 50 living within 25 miles of the London hospital.
Participants are randomly assigned to receive either the real procedure or a pretend procedure.
All participants receive 12 months of expert diet, exercise, and medical support.
The procedure takes under an hour using local numbing medicine, with no overnight hospital stay required.

Who may be eligible?

This study is open to adults aged 18 to 70 who have a body mass index (BMI) between 35 and 50 kg/m² and weigh under 150 kg (around 23 stone 8 lbs). Because you will need to attend regular hospital appointments, you must live within 25 miles of the hospital in West London and be able to lie flat on your back during tests.

You cannot join the trial if you have previously had major stomach surgery, weight-loss surgery, or radiation treatment to your tummy. It is also not suitable for people with severe kidney, liver, or heart disease, active stomach ulcers, bleeding problems, or those who have had cancer.

Additionally, you will not be able to participate if you are pregnant, take insulin or sulphonylurea tablets for diabetes, or regularly take steroid medications, certain antidepressants, or anti-inflammatory painkillers like ibuprofen. Doctors will perform blood tests and scans first to confirm whether the blood vessels in your stomach are suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 18 and 70 years old.
My BMI is between 35 and 50 kg/m² and I weigh less than 150 kg.
I live within 25 miles of Imperial College London.
I can comfortably lie flat on my back for medical tests.
I have never had weight-loss surgery or major stomach surgery.
I do not take insulin, regular steroid tablets, or daily anti-inflammatory painkillers.

Answer every question to see your result.

What does participation involve?

Taking part in the trial lasts for roughly 12 months. At the start, you will have health checks, including blood tests, blood pressure checks, a scan of your blood vessels, and an endoscopy (a small camera passed down your throat to look at your stomach lining). You will then be randomly assigned to receive either the real blood-vessel blocking procedure or a pretend procedure, which involves only a small needle prick in the wrist. Both take less than an hour under local anaesthetic, followed by about two hours of resting in hospital before you go home. Over the year, you will receive regular dietary and lifestyle coaching from specialist dietitians and doctors, alongside follow-up hospital visits to monitor your weight, health, and hormone levels.

Potential risks and benefits

You may benefit from weight loss and improvements in conditions linked to obesity, such as blood pressure and blood sugar levels, along with close medical attention from specialist doctors. However, weight loss cannot be guaranteed, particularly if you are in the pretend procedure group. The procedure is generally safe, but common mild risks include bruising, slight bleeding, or infection where the tube enters the wrist or groin (occurring in about 1 to 3 in 100 people). Rare side effects include temporary irritation to the stomach lining or inflammation of the pancreas. Taking part is completely your choice, and you can change your mind and leave the study at any time without your ordinary NHS care being affected.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Mary's Hospital
Unverified
London, England
University College Hospital
Unverified
London, England

Common questions

What is a 'sham' procedure?

A sham procedure is a dummy or pretend treatment. You will receive a small needle in your wrist under local anaesthetic, but no blood vessels are blocked. This allows researchers to fairly test whether the real procedure genuinely works.

Will the procedure be painful?

The procedure is done using local anaesthetic, which numbs the skin on your wrist or groin. Most people do not feel pain during the treatment, though you might feel slight pressure or mild tummy ache afterwards.

Do I need to stay in hospital overnight?

No. The procedure usually takes less than an hour, and you will stay in hospital for about two hours afterwards so the team can check on you before you return home on the same day.

Will I still get help with diet and exercise?

Yes. Every participant in the trial receives ongoing, personal advice on healthy eating and physical activity from a specialist dietitian and medical team.

Can I stop taking part if I change my mind?

Yes. You have the right to withdraw from the trial at any point without giving a reason, and your regular NHS medical care will continue as normal.

How to find out more

Claire Smith

embio@imperial.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.