RecruitingOBSERVATIONAL

Vascular Complications in Children From T1D Diagnosis

This research is investigating how Type 1 diabetes (T1D) might affect the heart and blood vessels in children and teenagers aged 8-18 years, right from when they are first diagnosed. While heart problems usually happen later in life for people with T1D, some studies suggest early changes can occur in younger people. This study aims to pinpoint exactly when these changes begin and what might cause them, focusing on children in Metro Vancouver, Canada. By understanding this better, doctors hope to find ways to protect the heart health of young people with Type 1 diabetes in the long term, helping them stay healthier as they grow up.

At a glance

Status

Recruiting

Sponsor

University of British Columbia

Enrolment target

150

Start

25 Mar 2024

Estimated completion

30 Sep 2027

Type 1 Diabetes Cardiovascular Complications Child Adolescent

What is this study about?

When children and teenagers are diagnosed with Type 1 diabetes, their bodies can't make a chemical called insulin, which helps turn sugar from food into energy. This means they need to take insulin medicine every day. Over many years, Type 1 diabetes can sometimes lead to other health problems, including issues with the heart and blood vessels. These are serious, but usually take a long time to show up, often in adulthood.

However, some smaller studies have hinted that very subtle changes to the heart and blood vessels might start in children with Type 1 diabetes even earlier than we thought – perhaps within the first year or two after they're diagnosed. Scientists don't fully understand when these changes begin, what exactly causes them, or how they develop. This particular study wants to learn more about this process.

By following children and teenagers from the moment they are diagnosed with Type 1 diabetes, the researchers hope to see exactly when and how any changes to their blood vessels happen. They'll also look at things like diet and physical activity. Understanding this early stage could be incredibly important, as it might help doctors find new ways to protect the heart health of young people with Type 1 diabetes, potentially preventing future problems and helping them live healthier lives.

Key takeaways

This study focuses on children and teenagers (8-18) newly diagnosed with Type 1 diabetes.
It aims to understand if and when heart and blood vessel changes might begin very early in the disease.
Participation involves five visits over two years for check-ups, blood tests, and special heart/blood vessel tests.
The research provides valuable insights but does not involve new treatments or change your child's existing care.
The findings could help improve long-term heart health for young people with Type 1 diabetes.

Who may be eligible?

To join this study, children need to be between 8 and 18 years old and have been diagnosed with Type 1 diabetes within the last 14 weeks. It's also important that they are able and willing to have a special test that checks their blood vessels, which takes about an hour, and are happy to wear a blood pressure monitor for 24 hours.

However, some conditions mean a child can't take part. This includes if they have other serious heart or hormone-related conditions, certain genetic conditions like Down Syndrome, or if they've been diagnosed with an eating disorder. Also, children who are taking hormone blockers or certain medications that affect their body's way of using energy (metabolism) will not be able to join.

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.

Is my child between 8 and 18 years old?
Was my child diagnosed with Type 1 diabetes within the last 14 weeks?
Is my child able and willing to have a blood vessel flexibility test (about 1 hour)?
Is my child able and willing to wear a blood pressure monitor for 24 hours?
Does my child have any other serious heart, hormone, or genetic conditions?
Is my child currently taking medications that affect their body's metabolism (e.g., certain steroids or antipsychotics)?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be followed for two years. They will need to visit the hospital (BC Children's Hospital in Vancouver, Canada) five times in total: once shortly after diagnosis, and then again at 6, 12, 18, and 24 months. At each visit, they will have a health check-up, answer some questions, give blood samples, and have tests to check their heart and blood vessels. This will include a special test for about an hour to see how flexible their arteries are, and they’ll also wear a blood pressure monitor for 24 hours to measure their blood pressure over a whole day. The study does not involve taking any new medications.

Potential risks and benefits

Taking part in a study like this helps improve our understanding of Type 1 diabetes and could benefit future generations of children with the condition. The main benefits are contributing to medical knowledge. There are minimal risks involved, mainly discomfort from blood tests and wearing the blood pressure monitor. All procedures are standard medical tests. Remember, participation is completely voluntary, and you are free to withdraw your child from the study at any time without explaining why, and it won't affect their regular medical care.

Locations (1)

Endocrine and Diabetes Unit, BC Children's Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is Type 1 diabetes?

Type 1 diabetes is a condition where the body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Insulin is a hormone vital for converting sugar from food into energy for our bodies. People with Type 1 diabetes need to take insulin daily to manage their blood sugar levels.

What does 'vascular damage' mean?

'Vascular damage' refers to harm to the blood vessels, which are the tubes that carry blood around your body. Over time, high blood sugar levels can make blood vessels less flexible and narrower, which can lead to heart problems. This study wants to see how and when these changes might start in children with Type 1 diabetes.

What is 'arterial stiffness'?

Arterial stiffness is a way of measuring how flexible your arteries (the main blood vessels) are. Healthy arteries are stretchy. If they become stiff, it can be a sign of early problems with the heart and blood vessels. This study will use a special test to check this.

Is this study a new treatment?

No, this study is not testing a new treatment or medicine. It's an observational study, meaning researchers are watching and learning about how Type 1 diabetes affects children over time. The goal is to understand the condition better, which could help guide future treatments.

Will my child's regular diabetes care change if they join?

No, your child's regular medical care for their Type 1 diabetes will continue as normal and will not be affected by their participation in this study. The study focuses on gathering information, not on changing their usual treatment plan.

How to find out more

Angela Devlin, PhD

adevlin@bcchr.ubc.ca 6048752000 Official trial record

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