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

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID: NCT07573917
Run by: Université de Sherbrooke
People needed: 15
Starts: 2025-09-24
Expected to finish: 2027-05-31
Last updated by the study team: 2026-05-07

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)
Alcohol consumption of >2 servings per day for man and >1 servings per day for women
Smoking
Being insulin-dependent and/or using SGLT2 inhibitor medications
Patients with congestive heart failure and and/or severe renal and or liver insufficiency
Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l
A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient will be excluded from enrolment.
Being pregnant
Having participated in another study involving PET/CT scanning in the past 1 year

Where it is running

Centre de recherche du CHUS — Sherbrooke, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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