Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
This research is looking at a new device called the Trans-Duodenal Barrier, which is a temporary implant for adults dealing with type 2 diabetes and obesity. It's a soft, tube-like liner placed inside the upper part of the small bowel using a flexible camera procedure (endoscopy). The main goal is to find out if this device is safe and if it helps lower blood sugar levels (measured by HbA1c), reduces excess weight, and potentially improves liver health in people with a condition called MASH. The device stays in for about six months and is then removed. Researchers will keep in touch to see how participants are doing during and after this period.
At a glance
What is this study about?
This study is exploring a new approach to help people who have both type 2 diabetes and obesity. It involves a device called the Trans-Duodenal Barrier, which is like a very soft, thin tube that’s placed inside your digestive system without surgery, using a procedure similar to an endoscopy (where a flexible camera is put down your throat). This device stays in place for about six months.
The main idea behind this device is to see if it can help improve how your body handles sugar and if it can lead to healthy weight loss. Researchers will be monitoring important health markers like your long-term blood sugar levels (HbA1c). They also want to understand if it helps people who have a related liver condition called Metabolic Associated Steatohepatitis (MASH) to see if their liver health improves. Once the six months are up, the device is removed through another simple endoscopic procedure.
This is an "approval study," which means the researchers are carefully checking that the device is both safe to use and that it works as intended before it can become more widely available. Your participation would help gather crucial information that could benefit many others in the future.
Key takeaways
- It's a study for a new device to help with type 2 diabetes and obesity.
- The device is a temporary implant placed using a special camera (endoscopy).
- It aims to lower blood sugar and reduce weight.
- The device stays in for 6 months and is then removed.
- Participants will have clinic visits during and after the implant period.
- It may also help liver health for those with MASH.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, who has both obesity and type 2 diabetes. You also need to be able to understand what the study involves and be willing to give your written permission to take part.
There are some reasons why you might not be able to join. For example, if you can't understand the study details, or if you live very far away (more than 100 km from the study centres in Germany). You also can't be pregnant, or already taking part in another study for diabetes or similar health conditions. This study is not for people who are unwilling to follow instructions during the study, or those under certain legal restrictions.
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 18 years old or older.
- I have both obesity and type 2 diabetes.
- I can understand what participating in a study means.
- I live within 100 km of one of the study locations in Germany.
- I am not pregnant.
- I am not currently in another diabetes or metabolism study.
What does participation involve?
If you decide to take part in this study, you would have the Trans-Duodenal Barrier device placed in your body for approximately six months. You'll need to visit one of the study clinics three times while the device is in place, and then once more for its removal. After the device is taken out, the research team will check in with you by phone about four weeks later. The full study involvement for each person lasts about 28 weeks in total.
Potential risks and benefits
Locations (8)
- Universitätsmedizin MannheimVerified postcodeMannheim, Germany
- Sozialstiftung BambergVerified postcodeBamberg, Germany
- Universitätsklinikum WürzburgVerified postcodeWürzburg, Germany
- Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische KlinikVerified postcodeBochum, Germany
- Städtisches Klinikum DresdenVerified postcodeDresden, Germany
- University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and PneumologyVerified postcodeLeipzig, Germany
- Klinikum St. Georg LeipzigVerified postcodeLeipzig, Germany
- Charite Universitätmedizin Berlin CVKVerified postcodeBerlin, Germany
Common questions
What is the Trans-Duodenal Barrier device?
It's a soft, tube-like liner placed temporarily in your gut to help with type 2 diabetes and obesity.
How is the device put in and taken out?
It's placed and removed using an endoscope, a flexible camera, without needing surgery.
How long will the device stay in my body?
The device stays in for about six months.
What health issues is this study trying to help?
It's for adults with type 2 diabetes, obesity, and potentially a liver condition called MASH.
Will I have to travel far for this study?
You need to live within 100 km of one of the study centres in Germany.
How to find out more
Georg Kähler, MD, Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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