RecruitingOBSERVATIONAL

The Sunnybrook Type 2 Diabetes Study

The Sunnybrook Type 2 Diabetes Study explores how Type 2 Diabetes and prediabetes are connected to mood and thinking problems. Researchers will follow people over time, looking at their lifestyle (like exercise, sleep, and diet), genes, and brain health using scans and samples. The study aims to understand why these issues happen and how they develop. It also looks at how different treatments, like an exercise and healthy lifestyle program, might help. By gathering a lot of information, from blood tests to brain scans, and even linking with health records, the study hopes to find better ways to support people with diabetes and prediabetes in the future.

At a glance

Status

Recruiting

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

500

Start

21 Dec 2017

Estimated completion

01 Dec 2026

Type 2 Diabetes PreDiabetes

What is this study about?

This research, called The Sunnybrook Type 2 Diabetes Study, is trying to understand more about Type 2 Diabetes and prediabetes. These are conditions where your body has trouble controlling blood sugar levels. The study is especially interested in how these conditions might affect your mood and your ability to think clearly, remember things, and make decisions. They want to find out why some people with diabetes or prediabetes experience these challenges, how these issues show up, and what long-term effects they might have.

The researchers are observing people over time, rather than giving them a new treatment. They are gathering lots of information – including details about participants' lifestyles, such as how much they exercise, how well they sleep, and what they eat. They are also collecting blood and urine samples to look at things like genes and other body markers. Some participants will also have special scans of their brain. All of this information helps scientists build a clearer picture of diabetes and its wider effects on health.

Ultimately, the goal is to improve the way we understand and care for people with Type 2 Diabetes and prediabetes. By learning more about the links between these conditions, mood, and thinking, the study hopes to pave the way for better support and treatments in the future. This could help people manage their diabetes more effectively and improve their overall quality of life.

Key takeaways

Study helps understand links between diabetes, mood, and thinking.
Participation involves health assessments, blood/urine samples, and optional brain scans.
Your current diabetes care will not change.
Results could lead to better future support for people with diabetes.
Participation is voluntary, and you can withdraw anytime.
Eligibility depends on age, English proficiency, and health conditions.

Who may be eligible?

To join this study, you need to be at least 18 years old and be able to speak English. You must also have either prediabetes (meaning your blood sugar levels are higher than normal but not yet high enough for a diabetes diagnosis) or already have a diagnosis of Type 2 Diabetes.

There are also some reasons why you might not be able to take part. For example, if you are pregnant, or if you have certain health conditions like a current cancer diagnosis, bipolar disorder, schizophrenia, or certain brain-related disorders. Also, if you’ve had a problem with drug or alcohol use in the last five years (other than nicotine), you wouldn't be able to join. There's also a short test to check your basic thinking abilities, and you'd need to score well on that.

If you're interested in the brain scan part of the study, there are extra checks. You can't have certain medical devices in your body that would interfere with the MRI machine. For another optional part that looks at blood flow in the brain, you can't have serious lung conditions like severe asthma or emphysema.

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 18 years old or older?
Can you speak and understand English?
Do you have Type 2 Diabetes or prediabetes?
Are you currently pregnant? (If yes, you can't join)
Do you have conditions like bipolar disorder, schizophrenia, or a recent severe substance use problem? (If yes, you can't join)
Do you have any medical devices that might be unsafe for an MRI scan? (Important for brain scan part)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several visits over about 18 months, usually at the start, then at 3, 6, and 18 months. During these visits, you'll have various assessments. This includes answering questions about your mood, how you're feeling, and your lifestyle (like how much you exercise, your sleep, and diet). You'll also do some tests to check your thinking and memory skills.

At each visit, you'll provide blood and urine samples. These samples help researchers look at your genes, blood sugar, and other health markers. Some participants will also have an optional brain scan (MRI) that takes about 1.5 hours. There are also opportunities to join two smaller, optional studies: one involving another MRI scan to look at blood flow in the brain, and another that involves wearing a small device overnight to check your sleep quality.

The researchers will also keep track of any medications or supplements you are taking. With your permission, they might also look at your health records to understand your long-term health and how you use health services. You wouldn't need to change any of your current diabetes care or medications to participate.

Potential risks and benefits

Taking part in this study won't directly improve your diabetes or mood, as it's observational – meaning researchers are watching and learning, not testing out new treatments. However, the information gathered from people like you is very important and will help doctors and scientists understand diabetes, mood, and thinking patterns better in the future. This could lead to better ways to support people in the long run. Potential risks are generally low, mainly involving the minor discomfort of blood draws, and the time commitment for appointments. For those having MRI scans, risks are related to the strong magnetic field, so careful checks are done beforehand. Remember, you can always choose to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Sunnybrook Research Institute
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is prediabetes?

Prediabetes means your blood sugar levels are higher than normal, but not yet high enough to be diagnosed as Type 2 Diabetes. It's a warning sign.

Will I get a new treatment for my diabetes if I join?

No, this is an observational study, meaning researchers are learning from you, not giving new treatments. Your current diabetes care will continue as usual.

How long does the study last?

You would be part of the study for about 18 months, with visits typically at the start, 3 months, 6 months, and 18 months.

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, like your brain.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, and your decision will not affect your medical care.

How to find out more

Walter Swardfager, PhD

w.swardfager@utoronto.ca 416-480-6100 Official trial record

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