AuthorisedTherapeutic exploratory (Phase II)Interventional

Visualizing beta cells in patients with a history of gestational diabetes.

This research is exploring a new way to look at special cells in the pancreas called 'beta cells'. These cells are very important because they make insulin, which helps your body control blood sugar. The study focuses on women who have had gestational diabetes, which is a type of diabetes that happens during pregnancy. Researchers are using a special type of scan, called a PET/CT scan, along with a tracing substance, to see how much of this substance is taken up by these beta cells. The main goal is to see if this scan can accurately measure these cells in women, both with and without a history of gestational diabetes. They also want to see if the amount of the tracing substance found by the scan is connected to how well these beta cells are working.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

13 Jan 2025

Gestational diabetes

What is this study about?

This study is about understanding more about a type of diabetes that can happen during pregnancy, called gestational diabetes. When you have gestational diabetes, your body doesn't make enough insulin, or doesn't use it properly, leading to high blood sugar levels. Special cells in your pancreas, called beta cells, are responsible for making insulin.

Researchers are using a new and innovative way to look at these beta cells. They're using a special scanning technique called a PET/CT scan. Before the scan, participants will receive a very small amount of a tracing substance. This substance is designed to attach specifically to the beta cells. The PET/CT scan then creates pictures that show how much of this tracing substance the beta cells have taken up. By looking at these pictures, the researchers hope to get a clearer idea of how many beta cells there are and how active they are.

This is important because understanding more about these beta cells could help us learn why some women develop gestational diabetes and what happens to these cells afterwards. The study will compare women who have had gestational diabetes with those who haven't, to see if there are differences in their beta cells that this new scanning method can detect. This research is in an early stage (Phase II), which means it's about exploring if this new scanning method works and if it can give us useful information.

Key takeaways

The study uses a special scan to look at cells important for insulin production.
It focuses on women who have had diabetes during pregnancy.
The aim is to understand more about how these cells work.
Participation involves a single scan after a tracing substance is given.
This research helps improve our understanding of gestational diabetes.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for both women who have had gestational diabetes and women who haven't. Participants need to be at least 18 years old.

The researchers will also check for other health conditions or medications you might be taking to make sure it's safe for you to participate and that your results will be accurate for the study.

It's important to understand that even if you meet the basic age and sex requirements, there might be other reasons you can't join the study. These will be discussed with you in detail if you are interested.

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 female?
Are you 18 years old or older?
Have you had gestational diabetes, or not?
Are you able to attend appointments for a scan?
Do you have any significant ongoing health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a special tracing substance, which is given in a very small amount, usually through an injection. This would be followed by a PET/CT scan, which is a specific type of imaging scan. The scan itself is painless, but you'll need to lie still for a period. The total duration of your involvement in the study, including preparation and the scan, would likely be for one visit. There may be some follow-up appointments or phone calls to check in on you. The study medicine mentioned (Exenatide) is what the tracing substance is based on, not necessarily a medicine you would take as part of the study; the focus is on the scan.

Potential risks and benefits

Taking part in a study like this helps advance medical knowledge, potentially leading to better understanding and treatment for gestational diabetes in the future. There are always some potential risks with medical procedures, such as minor discomfort from the injection or a small exposure to radiation from the scan, similar to what you'd get from other medical imaging. You will receive detailed information about these risks before deciding to take part, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What are beta cells?

Beta cells are special cells in your pancreas that make insulin, a hormone vital for controlling your blood sugar.

What is gestational diabetes?

It's a type of diabetes that develops during pregnancy, usually going away after the baby is born, but can increase future health risks.

What is a PET/CT scan?

It's a type of medical scan that helps doctors see how your organs and tissues are working by using a small amount of a tracing substance.

Will I have to take any medication?

The study involves a special tracing substance for the scan, but it's not a regular medication you'll take daily. The focus is on the scan itself.

How long will I be involved in the study?

Your direct involvement, mainly for the scan, will likely be for one day, though there might be some follow-up checks.