15 Participants NeededMy employer runs this trial

Cold Exposure for Type 2 Diabetes

FF
Overseen ByFrédérique Frisch
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Université de Sherbrooke
Must be taking: Metformin, Sulfonylureas, DPPIV inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether spending time in a mildly cold environment, enough to cause slight shivering, can help people with type 2 diabetes improve blood sugar control and heart health. Prior research has suggested that exposure to cold temperatures for a few hours each day can boost insulin sensitivity, especially when shivering occurs. Suitable candidates for this study have type 2 diabetes managed with oral medication, have maintained stable weight recently, and do not have significant heart or kidney issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new ways to manage type 2 diabetes.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you must be on a stable dose of certain diabetes medications like metformin, sulfonylurea agents, or DPPIV inhibitors for at least the last 3 months. If you are on GLP-1 agonist medication, your inclusion will be discussed with a physician.

What prior data suggests that this cold exposure method is safe for individuals with Type 2 Diabetes?

Research has shown that exposure to cold environments and shivering may benefit people with type 2 diabetes. One study found that spending time in slightly cold conditions for about 10 days improved the body's insulin use, crucial for blood sugar control. Another study discovered that shivering in the cold reduced fasting blood sugar levels for many participants.

While these studies highlight benefits, they also touch on safety. Most participants tolerated the cold exposure well, though specific side effects were not mentioned. As this trial continues to explore long-term safety, it suggests that while the treatment appears promising, further research is necessary to fully understand its safety. Participants should consider this when deciding to join the trial.12345

Why are researchers excited about this trial?

Unlike standard treatments for type 2 diabetes, such as medications that regulate blood sugar levels or insulin therapy, cold exposure with shivering offers a completely different approach. Researchers are excited about this method because it taps into the body's natural ability to increase energy expenditure and improve insulin sensitivity through cold-induced thermogenesis. This could potentially provide a non-pharmacological option that complements existing therapies, offering benefits without the need for additional drugs.

What evidence suggests that cold exposure with shivering might be an effective treatment for Type 2 Diabetes?

Research has shown that exposure to cold environments and shivering can benefit individuals with type 2 diabetes. Spending a few hours each day in mildly cold conditions increases the body's sensitivity to insulin, aiding in blood sugar control. One study found that 85% of participants experienced lower fasting blood sugar levels after shivering for one hour daily over 10 days. Another study demonstrated that cold exposure improved the body's sugar management and cholesterol levels, which are often concerns for those with diabetes. This trial will include a 10-day cold acclimation intervention with shivering. These findings suggest that such cold exposure might effectively manage blood sugar and support heart health in people with type 2 diabetes.14678

Who Is on the Research Team?

DP

Denis P. Blondin, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for adults aged 40-75 with type 2 diabetes diagnosed at least 1.5 years ago, whose blood sugar is fairly well controlled (HbA1c under 8.5%), have a BMI between 25 and 38, stable weight, and are on certain diabetes medications. Participants must not have active heart disease or other serious diabetes complications.

Inclusion Criteria

I am a woman who has not had a period for at least one year.
I was diagnosed with type 2 diabetes over 1.5 years ago.
My type 2 diabetes is well controlled with an HbA1c below 8.5%.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
2 visits (in-person)

Baseline Assessment

Participants receive physical activity, ambulatory blood pressure, and continuous glucose monitors; baseline hyperinsulinaemic-euglycaemic clamp measurement is conducted

1 week
2 visits (in-person)

Cold Acclimation

Participants undergo 10 consecutive daily shivering sessions with various metabolic assessments

10 days
10 visits (in-person)

Post-intervention Assessment

Post-intervention hyperinsulinaemic-euglycaemic clamp measurement and collection of activity and ABP monitors

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 days
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cold exposure with shivering

Trial Overview

The study tests whether spending time in mildly cold environments that cause shivering for about an hour daily over ten days can improve insulin sensitivity and fat metabolism in people with type 2 diabetes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cold acclimation with shiveringExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+

Maastricht University Medical Center

Collaborator

Trials
992
Recruited
3,304,000+

Citations

Metabolic responses to mild cold acclimation in type 2 ... - PMC

Cold acclimation has been shown to have beneficial metabolic effects, including improved insulin sensitivity in patients with type 2 diabetes.

Examining the benefits of cold exposure as a therapeutic ...

Short-term cold acclimation improves insulin sensitivity in patients with type 2 diabetes mellitus. Nat Med 21: 863–865, 2015. Crossref · PubMed · Web of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39643644/

Cold acclimation with shivering improves metabolic health ...

We find that cold acclimation with shivering improves oral glucose tolerance, fasting glucose, triglycerides, non-esterified fatty acid concentrations and ...

Could Cold Exposure, Especially Shivering, Combat Type ...

Sellers found that 10 daily 1-hour sessions of shivering at 10°C led to 85% of participants showing a drop in fasting glucose, and a 32% drop in ...

Deliberate Cold Exposure as Augmentation for Diabetic ...

CE on Diabetes. One study compared the effects of CE on individuals with and without type 2 diabetes. The individuals with diabetes had had ...

The effect of cold exposure with shivering on glucose ...

Furthermore, we showed that cold acclimation increased insulin sensitivity (11), and others have shown immediate reductions in plasma glucose concentration ...

Cold exposure could help combat type 2 diabetes ...

The findings showed that repeated cold-induced shivering significantly reduced average fasting plasma glucose concentrations from 5.84 to 5.67 ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33090911/

The effect of cold exposure with shivering on glucose ...

We hypothesized that cold exposure, with shivering, would subsequently increase glucose tolerance. Fifteen healthy men (age = 26 ± 5 yr, body ...