RecruitingNAINTERVENTIONAL

Improving Insulin Sensitivity in Patients With Type 2 Diabetes Via Repeated Cold-induced Shivering Thermogenesis

This study explores a new idea: using mild cold exposure and shivering to help people with Type 2 Diabetes improve their blood sugar control and heart health. While healthy eating and exercise are important, they can be hard to stick with long-term. Previous research suggests that spending time in cool temperatures (around 15-17°C) for a few hours a day, especially when it causes mild shivering, might improve how the body responds to insulin. Researchers want to see if 10 days of these 'cold shivering' sessions can help people with Type 2 Diabetes become more sensitive to insulin. This could mean their bodies use sugar more effectively, potentially leading to better overall health. The study will involve regular check-ups and special tests to see how these cold sessions affect the body's metabolism.

At a glance

Status

Recruiting

Phase

Sponsor

Université de Sherbrooke

Enrolment target

Start

24 Sep 2025

Estimated completion

31 May 2027

Type 2 Diabetes

What is this study about?

Type 2 Diabetes is a common condition where the body struggles to keep blood sugar levels balanced. Over time, this can lead to other serious health problems like heart disease and high blood pressure, and can impact your overall quality of life. We know that eating a healthy diet and being active are really important for managing Type 2 Diabetes. However, it can be tough for many people, especially older adults or those with physical limitations, to maintain these habits consistently.

This research is looking into an interesting new approach: whether getting a bit cold and shivering could help. Earlier studies hinted that spending a few hours a day in a cool place (around 15-17°C or 59-63°F) could make the body better at using insulin, but only if it caused a little shivering. Insulin is the hormone that helps move sugar from your blood into your cells for energy. If your body uses insulin more effectively, it can help keep your blood sugar levels in a healthier range.

In this study, called an 'acclimation' study, participants will have daily sessions of mild cold exposure designed to make them shiver gently for about 10 days. The researchers want to see if these repeated shivering sessions improve how well the body uses insulin and processes fats, which are issues for people with Type 2 Diabetes. They believe that this muscle activity caused by shivering could be key to these improvements. The study will carefully measure changes in the body before, during, and after these cold sessions to understand exactly how it works.

Key takeaways

This study explores if mild cold exposure with shivering can help manage Type 2 Diabetes.
It aims to improve how the body uses insulin and processes fats.
Participation involves 10 daily cold sessions and several hospital visits for tests.
The cold is mild, designed to cause gentle shivering, not extreme discomfort.
It's a new approach researched alongside existing treatments like diet and exercise.
You would contribute to understanding new ways to help people with Type 2 Diabetes.

Who may be eligible?

To join this study, we're looking for women who have gone through menopause and both men and women who are generally between 40 and 75 years old. Your Body Mass Index (BMI) should be between 25 and 38. You should have been diagnosed with Type 2 Diabetes for at least 18 months and be managing it fairly well, with an HbA1c (a measure of average blood sugar) below 8.5%. You should be on certain diabetes medications, like metformin, perhaps with sulfonylureas or a DPPIV inhibitor, and these medications should have been stable for the last three months.

There are also some important reasons why you might not be able to join. If you've had major changes in your weight recently (more than 5kg or about 11 pounds in the last three months), or if you smoke or drink a lot of alcohol, you won't be eligible. We also can't include people who are already used to the cold (for example, by taking daily cold baths or swimming in cold water regularly) or who exercise very intensely more than three times a week. People with certain serious heart, kidney, or liver problems, or who are using insulin or SGLT2 inhibitor medications for diabetes, won't be able to take part.

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 between 40 and 75 years old?
Are you a woman who has gone through menopause, or a man?
Have you been diagnosed with Type 2 Diabetes for at least 1.5 years?
Is your diabetes generally well-controlled (HbA1c below 8.5%)?
Are you on metformin, or metformin with sulfonylureas or a DPPIV inhibitor?
Do you not regularly exercise intensely or spend daily time in extreme cold?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll visit the research centre a number of times over a few weeks. On your first visit, you'll get some devices to wear, like a physical activity tracker and monitors for your blood pressure and blood sugar. A couple of days later, you'll return for some baseline tests, including a special measurement of how your body uses insulin.

The main part of the study involves 10 daily sessions of mild cold exposure, where you'll be encouraged to shiver. During the first and last of these cold sessions, you'll have detailed scans to see how your body uses fats. Throughout these 10 days, regular blood samples will be taken, and some visits will involve checks on your skin temperature, muscle activity, and blood pressure. After the 10 cold sessions, you'll have another insulin test, similar to the one at the start. You'll wear the activity and blood pressure monitors again for a while, and then return for a final visit to hand them back. The total time you'd be actively involved in the hospital visits and testing would be over a few weeks.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as a better understanding of how your body reacts to the cold and its impact on your diabetes, and you would be contributing to new medical knowledge. However, as with any study, there are potential risks, including discomfort from feeling cold and shivering, or from blood samples and other tests. You might also find the time commitment challenging. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre de recherche du CHUS
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is 'cold-induced shivering thermogenesis'?

It's a fancy way of saying your body makes heat by shivering when it gets cold. This study looks at whether this shivering can help manage blood sugar.

Will I be really, really cold?

The cold exposure is designed to be mild (around 15-17°C / 59-63°F) and to cause gentle shivering, not to be extremely uncomfortable.

How long will each 'cold session' last?

Each cold exposure session is planned for a specific duration, tailored to encourage mild shivering. More detailed timing would be provided if you were to participate.

Are there any side effects from the cold exposure?

You might feel chilly and shiver during the sessions. The research team will monitor you closely to ensure your safety and comfort.

Will I have to stop my current diabetes medication?

No, you will generally continue your diabetes medication as usual, provided it meets the study criteria. The study specifically looks at how your current treatment works alongside this new intervention.

How to find out more

Frédérique Frisch

frederique.frisch@usherbrooke.ca 819-346-1110 Official trial record

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