AuthorisedTherapeutic exploratory (Phase II)Interventional

A GLP-1 receptor PET imaging add-on study within the VERA-T1D trial investigating the effects on beta cell mass (Image-VER-A-T1D)

This study, called "Image-VER-A-T1D," is investigating how two different medications, exenatide and verapamil, might impact the insulin-producing cells (beta cells) in the pancreas of adults with type 1 diabetes. Researchers are particularly interested in seeing if these treatments can help protect or even increase the number of these important cells. To do this, they will use a special imaging scan, called a PET scan, at the beginning of the study and again after 12 months. This scan helps them measure how many of these beta cells are present. The study also aims to see if changes in these cells relate to other measurements of how the pancreas is working, like C-peptide and proinsulin levels. This is a phase II study, meaning it's an early-stage trial trying to understand if the treatments are safe and what effects they have.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

30 Jan 2025

type 1 diabetes mellitus

What is this study about?

This study is called Image-VER-A-T1D, and it's looking into type 1 diabetes. We know that in type 1 diabetes, the body's immune system mistakenly attacks and destroys the beta cells in the pancreas. These are the special cells that make insulin, which is essential for controlling blood sugar levels. Without enough insulin, people need to take it regularly.

The main goal of this study is to see if two different medications, exenatide and verapamil, can help protect or even increase the number of these important insulin-producing cells. Participants in the study will already be taking either exenatide or verapamil as part of a larger trial (VERA-T1D). This particular part of the study will use a special type of scan called a PET scan. This scan uses a very small amount of a safe, temporary marker that helps highlight the beta cells in the pancreas. By doing this scan at the start of the study and again after 12 months, the researchers hope to see if there are any changes in the amount of beta cells.

Understanding if these medications can preserve or increase beta cells is really important. If successful, it could potentially lead to better ways to manage type 1 diabetes in the future by helping people keep more of their own insulin production. The study also aims to compare the results of these scans with other tests that measure how well the pancreas is working, such as C-peptide and proinsulin levels.

Key takeaways

This study uses special scans to look at insulin-making cells in type 1 diabetes.
It's an add-on to a larger trial testing exenatide and verapamil.
The aim is to see if these drugs help protect or increase beta cells.
You'll have two scans, one at the start and one after 12 months.
Both men and women aged 18+ can take part if they are in the main study.

Who may be eligible?

To be able to join this special imaging part of the study, you need to already be taking part in the larger VERA-T1D trial. This means you would already be receiving either exenatide or verapamil as part of your care.

The study is for adults aged 18 and over. There is no upper age limit, meaning people of all adult ages can take part, as long as they meet the other study requirements.

Both men and women are welcome to join this study. The medical team will check other health details to make sure it's safe for you to have the special scans and take part.

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 currently taking part in the VERA-T1D study?
Are you aged 18 years or older?
Are you comfortable with having special medical scans?
Do you already receive either exenatide or verapamil through the VERA-T1D study?

Answer every question to see your result.

What does participation involve?

If you are already in the VERA-T1D study, taking part in this imaging add-on involves two main visits for a special scan. You'll have one scan at the very beginning of this imaging study. Then, after 12 months, you'll have a second scan. Each scan involves a small, safe injection of a tracer that helps doctors see your pancreatic cells. You will also have blood tests alongside these scans. The total duration for this imaging part of the study is 12 months, matching the period between your two scans.

Potential risks and benefits

A potential benefit is that this study helps us learn more about type 1 diabetes and how certain treatments might affect the cells that make insulin. This could lead to better treatments in the future. As with any medical procedure, there are some potential risks. The special scan involves a small amount of radiation, similar to other medical scans, but deemed safe for study purposes. The injection might cause a brief discomfort. All procedures and potential risks will be fully explained by the study team. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (2)

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

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Unverified
Austria
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Unverified
France

Common questions

What is a PET scan?

A PET scan is a special type of imaging scan that helps doctors see how organs and tissues are working. For this study, it helps us look at the cells in your pancreas.

What are exenatide and verapamil?

These are two different medications being tested in this study. They are thought to potentially help protect or improve the insulin-producing cells in the pancreas.

What are beta cells?

Beta cells are special cells in your pancreas that produce insulin, which is a hormone crucial for managing your blood sugar levels.

Will this study change my diabetes treatment?

This imaging study is an add-on to a larger trial. Your diabetes treatment will continue as per the VERA-T1D protocol, which is providing either exenatide or verapamil.

How much radiation will I be exposed to?

The PET scan involves a very small amount of radiation, similar to what you might experience with other common medical scans. The study team will explain this in detail.