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AuthorisedTherapeutic exploratory (Phase II)Interventional

PLatelet aggregation and Aspirin low response in Type One Diabetes and the association with vascular damage and diabetic Nephropathy

This study aims to understand how blood cells called platelets clump together in people with Type 1 diabetes, both with and without taking aspirin. We're particularly interested in how this clotting is affected by kidney problems (diabetic kidney disease) and if it links to damage to blood vessels that can lead to heart disease. Researchers will compare platelet activity in people with Type 1 diabetes to healthy individuals. This research could help us learn more about why some people with diabetes are at higher risk of heart problems and how aspirin might play a role in their treatment. This is an early-stage study, meaning we are still exploring these ideas.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Steno Diabetes Center Copenhagen
Enrolment target
332
Start
22 Jan 2025

What is this study about?

This research study is about understanding how blood clots form in people living with Type 1 diabetes. We know that people with Type 1 diabetes can sometimes have problems with 'atherosclerotic cardiovascular disease,' which is when fats and other substances build up in your arteries, making them harder and narrower. They can also develop 'diabetic kidney disease,' which affects how well their kidneys work. Aspirin is a medicine often used to help prevent blood clots.

One of the key things we're looking at is how blood platelets, which are tiny cells in your blood that help it to clot, behave in people with Type 1 diabetes. We want to see if their platelets clump together differently compared to healthy people, especially if they have kidney problems. We're also interested in whether aspirin changes this clumping and if it works as expected. By studying this, we hope to find out if there's a link between how platelets clot and the development of problems like hardened arteries or kidney disease.

Ultimately, this study aims to explore new ways to protect people with Type 1 diabetes from serious health issues. Understanding how platelets work and how aspirin affects them could help doctors in the future to better prevent and manage heart and kidney complications in people with Type 1 diabetes. This is an early stage of research, meaning we are gathering basic information to help plan future, larger studies.

Key takeaways

  • This study explores blood clotting in Type 1 diabetes.
  • It investigates how aspirin affects blood clots in people with Type 1 diabetes, especially those with kidney issues.
  • Researchers will examine blood vessels (carotid arteries) for damage.
  • The study aims to understand links between clotting, blood vessel health, and kidney disease.
  • Participation involves blood tests, possibly taking aspirin, and follow-up appointments.
  • This is an early-stage study to gather important information for future research.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

We are looking for people with Type 1 diabetes, including those who may or may not be taking aspirin, and those who have different levels of kidney health, particularly if they have early signs of kidney damage (something doctors call 'albuminuria'). We also need healthy volunteers to compare against.

Specific details about your health and medications will be checked carefully by the study team to make sure this study is right for you and safe for you to participate.

Quick self-check
  • Are you 18 years old or older?
  • Do you have Type 1 diabetes?
  • Are you open to having blood tests and possibly taking aspirin if not already prescribed?
  • Are you able to attend follow-up appointments over a period of time?
  • Do you understand that the study may involve checking your blood vessels?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would likely have some appointments involving blood tests to check how your platelets are working, both before and after potentially taking aspirin for a short period (at least seven days). Researchers will also check your blood vessels, particularly those in your neck (carotid arteries), to look for any signs of plaque build-up.

Over a period of time, possibly two years or more, you would have follow-up visits to see if there are any changes in your blood vessels or overall health. You would also have assessments to measure your overall health and how your body is working. The study will track your health using existing medical records as well. The total duration of your active involvement in the study could involve multiple visits and a follow-up period.

Potential risks and benefits

Potential benefits of taking part include contributing valuable information that could help improve the health of people with Type 1 diabetes in the future. You will also receive careful monitoring of certain health aspects throughout the study. Potential risks are generally low, mainly related to blood draws (like bruising or discomfort) and any side effects from aspirin, if you are asked to take it. Remember, participating is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and it won't affect your usual medical care.

Locations (1)

  • Denmark

Common questions

What is 'platelet aggregation'?

Platelet aggregation is simply the way tiny blood cells called platelets stick together to form a clot. This is important for stopping bleeding, but too much clumping can lead to problems like heart attacks or strokes.

What is 'albuminuria'?

Albuminuria is when a small amount of a protein called albumin is found in your urine. This can be an early sign of kidney problems, especially in people with diabetes.

Why is this study looking at aspirin?

Aspirin is often used to make blood less sticky and prevent clots. This study wants to see how well it works, or if it works differently, in people with Type 1 diabetes, particularly if they have kidney issues.

What is meant by 'vascular damage'?

Vascular damage refers to any harm or changes to your blood vessels, like arteries becoming harder or narrower due to plaque build-up, which can lead to heart disease.

Will I have to take new medicine if I join?

You might be asked to take aspirin for a short period if you're not already on it, as part of understanding its effects. The study team will discuss this with you fully.

How to find out more

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

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