About 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.
Eligibility criteria
Qualifiers
Patients are able to provide signed and dated written informed consent prior to any study specific procedures
Women are post-menopausal (defined as at least 1 year post cessation of menses)
Aged ≥ 40 years and ≤ 75 years
Patients should have suitable veins for cannulation or repeated venipuncture
Disqualifiers
Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
Participate in sports of physical activity at a moderate- to high-intensity more than 3 times a week, or as judged by the investigator
Being cold-acclimated, e.g. having taken daily extended cold baths, working in a refrigerated environment, or practicing regular cold-water swimming/ showering within 1 month of starting the study
Unstable body weight (weight gain or loss > 5 kg in the last three months)
Trial design
Treatments tested in this trial
- Cold exposure with shivering
Treatment groups
Sponsors and collaborators
Université de Sherbrooke
Lead sponsor
Maastricht University Medical Center
Collaborator