Study on Aspirin’s Effect on Platelet Aggregation in Patients with Type 1 Diabetes, Atherosclerotic Cardiovascular Disease, and Diabetic Kidney Disease

2 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of Type 1 Diabetes on blood clotting and its connection to heart and kidney health. The study will use a medication called Acetylsalicylic Acid, commonly known as aspirin, which is taken as an oral solution. The trial will explore how well aspirin works in people with Type 1 Diabetes, especially in relation to blood clotting and its potential impact on blood vessels and kidney function.

The purpose of the study is to understand how blood platelets, which help with clotting, behave in people with Type 1 Diabetes compared to healthy individuals. The study will also look at the presence of plaques, which are fatty deposits in the arteries, and how they relate to blood clotting in people with diabetes. Participants will be observed over a period of time to see if aspirin affects these factors and if it can predict changes in artery health or the risk of heart disease.

Participants will be monitored for changes in their blood clotting and artery health, with some taking aspirin for at least seven days. The study will also investigate the relationship between blood clotting and inflammation, which is the body’s response to injury or infection, in people with Type 1 Diabetes. The trial aims to provide insights into how these factors might predict future health outcomes related to heart and blood vessel health.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of type 1 diabetes and ensuring the participant is over 18 years of age.

Participants must be capable of providing informed consent to proceed with the study.

2 baseline evaluation

A baseline evaluation is performed to measure platelet aggregation without any aspirin treatment. This involves a blood test to assess how platelets, which are small blood cells, clump together.

The degree of albuminuria, which is the presence of a protein called albumin in the urine, is also measured to understand kidney function.

3 aspirin treatment

Participants begin taking acetylsalicylic acid, commonly known as aspirin, orally. The dosage and frequency are determined by the study protocol.

The treatment lasts for a minimum of seven days to evaluate its effect on platelet aggregation.

4 post-treatment evaluation

After the aspirin treatment period, another evaluation of platelet aggregation is conducted to compare results with the baseline.

The presence and volume of plaques in the carotid arteries, which are blood vessels in the neck, are assessed using imaging techniques.

5 follow-up assessments

Participants undergo periodic follow-up assessments to monitor changes in plaque volume and platelet aggregation over time.

These assessments help determine if there is a progression in plaque volume and its potential impact on cardiovascular health.

6 final evaluation

A final evaluation is conducted to examine the long-term effects of aspirin treatment on platelet aggregation and vascular health.

The study aims to understand the relationship between platelet function, plaque volume, and cardiovascular outcomes in individuals with type 1 diabetes.

Who Can Join the Study?

  • Must have Type 1 diabetes. (This is only for people with Type 1 diabetes.)
  • Must be a male or female participant who is older than 18 years.
  • Must be capable of giving informed consent. (This means you understand the study and agree to participate.)

Who Cannot Join the Study?

  • Having atherosclerotic cardiovascular disease, which is a condition where the blood vessels become narrowed or blocked due to a buildup of cholesterol and fats.
  • Having Type 1 diabetes, a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Having diabetic kidney disease, which is a complication of diabetes that affects the kidneys’ ability to function properly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Steno Diabetes Center Copenhagen Herlev Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
12.05.2020

Trial locations

Investigated drugs:

Aspirin is a medication commonly used to reduce pain, fever, or inflammation. In this clinical trial, it is being studied for its effects on platelet aggregation in people with Type One Diabetes. Platelet aggregation is a process where blood cells called platelets clump together, which can lead to blood clots. The trial aims to understand how well aspirin works in preventing this clumping in diabetic patients, especially those with different levels of kidney damage, compared to healthy individuals.

Investigated diseases:

Atherosclerotic cardiovascular disease – This disease involves the buildup of fatty deposits, known as plaques, in the walls of arteries. Over time, these plaques can harden and narrow the arteries, reducing blood flow. The progression of the disease can lead to the arteries becoming completely blocked. This blockage can result in reduced oxygen supply to vital organs. As the disease advances, it can cause complications such as chest pain or heart attacks. The condition can affect various arteries throughout the body, including those in the heart, brain, and limbs.

Type 1 diabetes – This is an autoimmune condition where the body’s immune system attacks and destroys insulin-producing cells in the pancreas. As a result, the body produces little or no insulin, a hormone necessary for glucose to enter cells and produce energy. The disease typically develops in childhood or adolescence but can occur at any age. Without insulin, blood sugar levels rise, leading to symptoms such as increased thirst, frequent urination, and fatigue. Over time, high blood sugar levels can cause damage to various organs and tissues. The progression of the disease requires careful management of blood sugar levels.

Diabetic kidney disease – This condition is a complication of diabetes that affects the kidneys. It occurs when high blood sugar levels damage the blood vessels in the kidneys, impairing their ability to filter waste from the blood. As the disease progresses, it can lead to the leakage of protein into the urine, a condition known as albuminuria. Over time, the kidneys may lose their function, leading to chronic kidney disease. The progression can eventually result in kidney failure if not managed properly. This condition requires monitoring and management to slow its progression.

Trial ID:
2024-520324-29-00
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of Colchicine to Reduce Complications in People with Type 1 Diabetes and High Blood Sugar Variability

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Using glucagon and automated insulin delivery to prevent low blood sugar during exercise in adults with type 1 diabetes

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark