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?

Type 2 Diabetes Mellitus (T2DM) is a widespread health condition characterized by impaired ability of the body to maintain glucose homeostasis. This impairment often leads to secondary complications, including heart disease, high blood pressure, and poor quality of life. While exercise and healthy eating are effective strategies in managing and preventing T2DM, data shows that long-term adherence to these methods are poor - especially among elderly, individuals with obesity and/or with physical limitations.

This clinical study explores cold exposure with shivering as a novel strategy to improve blood sugar control and heart health. In earlier research, spending time in mildly cold environments (around 15-17°C) for a few hours a day improved insulin sensitivity of T2DM patients. Interestingly, these benefits only occurred when the cold caused mild shivering. In a recent 10-day cold acclimation study with overt shivering for minimally 1 hour/day, we observed improved glucose tolerance in participants with overweight/obesity, as well as improved fasting lipid profiles. These results indicate that when accompanied with sufficient level of muscle activation, repeated exposure to cold can beneficially affect both glucose and lipid levels - both of which are impaired in people with T2DM.

In this study, we hypothesise that a 10-day cold acclimation with shivering will improve the (peripheral) insulin sensitivity of patients with T2DM, accompanied by enhanced skeletal muscle FA uptake and oxidation as assessed via the 11C palmitate uptake.

Who Is on the Research Team?

DP

Denis P. Blondin, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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%.
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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

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+