RecruitingNAINTERVENTIONAL

Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial

This research study is investigating a new way to help people with type 2 diabetes and obesity. It's called endoscopic gastroplasty and uses a special tool called the Endomina device to reduce the size of the stomach from the inside, without traditional surgery. Researchers want to see if this procedure, combined with usual care, is more effective at putting type 2 diabetes into remission compared to just receiving standard care alone. The study will follow people for two years after the procedure to check how well it works and whether their diabetes improves. This is a multi-centre study, meaning it's happening in several locations, and will involve randomly assigning people to either have the procedure or receive standard care.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

200

Start

29 Sep 2023

Estimated completion

01 Dec 2028

Diabetes Mellitus, Type 2 Obesity

What is this study about?

This study is designed to explore a new approach for individuals living with type 2 diabetes and a certain level of obesity. It focuses on a procedure known as endoscopic gastroplasty, which uses a special device called Endomina. Think of it as a way to make the stomach smaller from the inside using a flexible tube inserted through the mouth, rather than traditional surgical cuts. The main goal is to see if this method, combined with the usual care people receive for their diabetes and weight, can help put their type 2 diabetes into remission more effectively than receiving just the standard care.

Type 2 diabetes remission means that blood sugar levels return to normal without the need for diabetes medication. The researchers will be closely watching participants for 24 months (two years) after the procedure to understand its long-term effects on diabetes and overall health. This kind of research is really important because it could offer new options for managing type 2 diabetes and obesity.

The study is a 'randomised controlled trial'. This means that some people will be chosen by chance to have the Endomina procedure plus standard care, while others will receive standard care only. Neither you nor the doctors can choose which group you are in. This helps ensure the results are fair and that any differences seen are truly due to the new procedure. If you decide to take part, you'll be contributing to valuable medical knowledge that could help many others in the future.

Key takeaways

This study evaluates a new stomach-reduction procedure for type 2 diabetes and obesity.
It aims to see if the procedure can help put type 2 diabetes into remission.
Participants will receive either the procedure plus standard care, or standard care alone.
The study lasts for two years and involves regular check-ups.
It's for people with newly diagnosed type 2 diabetes and a specific BMI range.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would typically need to be between 18 and 65 years old. You should have been diagnosed with type 2 diabetes within the last 10 years, and it should be well-managed with your current non-insulin medications (like metformin or similar types of tablets or injections). Your average blood sugar level (HbA1c) should be below 9%. Your Body Mass Index (BMI) also needs to be in a specific range, usually between 30 and 34.9, though there are slight differences for people of Asian heritage.

There are also some reasons why you might not be able to join. For example, if you have type 1 diabetes, or certain severe health problems like advanced kidney or liver disease, serious heart conditions, or cancer within the last five years. You also can't be pregnant or breastfeeding. The study also wouldn't be suitable if you've recently had other stomach surgery, have past or current serious mental health conditions like severe depression, psychosis, bipolar disorder, or eating disorders such as bulimia, or if you have issues with alcohol or drug addiction. You must also be able to understand and agree to all the study requirements.

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.

Are you between 18 and 65 years old?
Were you diagnosed with type 2 diabetes less than 10 years ago?
Is your diabetes currently managed without insulin?
Is your BMI roughly between 30 and 35 (or 27.5-32.5 for Asian populations)?
Do you feel you can attend all study appointments for two years?
Do you NOT have serious kidney, liver, heart, or cancer within the last 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of two groups: either receiving the Endomina procedure along with your usual care, or just continuing with your usual care. Both groups will be closely monitored. This will involve regular visits to the clinic over two years. During these visits, the study team will take measurements, and conduct various assessments and tests to see how you're doing and how your diabetes is responding. You'll need to follow specific dietary advice and attend all scheduled appointments. Your medical information will be collected throughout this period. The total duration of your participation in the study, including all follow-up appointments, will be 24 months (two years). You'll be given detailed information about all the study requirements before you make a decision.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as receiving close medical attention and potentially benefiting from a new treatment that could improve your diabetes. However, like any medical procedure, the Endomina gastroplasty carries potential risks, including side effects from anaesthesia, discomfort, bleeding, or infection, though these are generally uncommon. The research team will explain all known risks associated with the procedure and participating in the study. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Chu Grenoble Alpes
Verified postcode
La Tronche, France· Recruiting

Common questions

What is endoscopic gastroplasty?

It's a way to reduce the size of your stomach from the inside using a special tool that goes through your mouth, without needing traditional open surgery.

What is the Endomina device?

It's the specific tool used during the endoscopic gastroplasty procedure to create stitches inside the stomach and make it smaller.

What does 'diabetes remission' mean?

It means your blood sugar levels are back to normal without needing diabetes medication.

Will I know if I'm getting the procedure or standard care?

No, this is a 'randomised' study, meaning you'll be assigned to a group by chance, and you won't know which one initially to make the study fair.

How long will the study last if I join?

If you participate, you will be followed by the study team for a total of two years.

How to find out more

L. LECLERCQ, MSc

estime@endotools.be +3271919409 Official trial record

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