Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• Body mass index (BMI) 25-38 kg/m2

• Stable dietary habits (no weight loss or gain \>5kg in the past 3 months)

• Diagnosed with T2D at least 1.5 years before the start of the study

• Relatively well-controlled T2D: HbA1c \< 8.5%

• Oral glucose-lowering medication: metformin alone or in combination with sulfonylurea agents and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months. In case of GLP-1 agonist medication treatment inclusion will be discussed with the dependent physician.

• No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy

• No signs of active liver or kidney malfunction

Locations
Other Locations
Canada
Centre de recherche du CHUS
RECRUITING
Sherbrooke
Contact Information
Primary
Frédérique Frisch
frederique.frisch@usherbrooke.ca
819-346-1110
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 15
Treatments
Experimental: Cold acclimation with shivering
This is a single-arm longitudinal study with a 10-day cold acclimation intervention period. Pre- and post-intervention measurements will be obtained before and after the 10-day period.
Sponsors
Leads: Université de Sherbrooke
Collaborators: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov