Using repeated mild cold exposure with shivering to improve insulin sensitivity in type 2 diabetes
Official title: Improving Insulin Sensitivity in Patients With Type 2 Diabetes Via Repeated Cold-induced Shivering Thermogenesis
Run by Université de Sherbrooke · NCT07573917 · Data updated 2026-11-12
We will try repeated daily mild cold exposures that cause short bouts of shivering to see if they improve insulin sensitivity and blood sugar control in adults 40–75 with type 2 diabetes on stable oral medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | May 31, 2027 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07573917 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40–75 with type 2 diabetes diagnosed >1.5 years, BMI 25–38 kg/m2, relatively well controlled (HbA1c <8.5%) on stable oral therapies (typically metformin ± other oral agents), with no active diabetes complications and who can tolerate daily cold-induced shivering and attend clinic visits.
✕Probably not a fit
Patients with active cardiovascular disease, significant diabetes complications (e.g., active foot disease, retinopathy, advanced neuropathy), unstable glycemic control, insulin-only regimens, or who cannot tolerate cold or daily clinic attendance are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will undergo a 10-day cold-acclimation program with daily controlled cold sessions eliciting mild shivering, with metabolic measurements taken before, during and after the intervention. Baseline and post-acclimation hepatic and peripheral insulin sensitivity will be measured using a two-step hyperinsulinaemic-euglycaemic clamp, and organ-specific fatty acid uptake and metabolism will be measured with 11C-palmitate PET/CT on the first and last cold exposure days. Continuous glucose monitoring, ambulatory blood pressure, indirect calorimetry, skin temperature, surface electromyography, and repeated blood sampling will be collected to track physiological responses and heat loss during the acclimation period. Most visits occur at the research center and include several clinic-based procedures that require suitable venous access and daily attendance over the 10-day intervention.
Why it matters
Potential benefit: If successful, this approach could improve insulin sensitivity and glucose control and offer an alternative or adjunct for people with limited ability to exercise.
How similar studies have gone: Small prior studies have reported improved insulin sensitivity and glucose tolerance from mild cold exposure when shivering occurred, but larger confirmatory trials are still lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
-
Centre de recherche du CHUS
Sherbrooke, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Denis P. Blondin, PhD — Université de Sherbrooke
- Study coordinator: Frédérique Frisch
- Email: frederique.frisch@usherbrooke.ca
- Phone: 819-346-1110
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Acute Blood Flow Restriction Walking in Type 2 Diabetes
This study tests whether adding blood flow restriction to treadmill walking affects immune cells in adults with type 2 diabetes.
-
Continuous Glucose Monitoring in Type 2 Diabetes Not on Insulin
This study tests whether using a continuous glucose monitoring system helps people with type 2 diabetes who aren’t using insulin to improve blood sugar control and quality of life.
-
Differentiating heart disease in autoimmune vs. type 2 diabetes
This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.
-
Lifestyle Metabotype Study B: Understanding Personalized Glucose Responses
This study tests how lifestyle, metabolism, and brain energy use relate to each person’s blood sugar response after meals, across people with and without prediabetes or type 2 diabetes.
-
Lifestyle Metabotype Study: How Daily Habits Shape Blood Sugar
This observational study tests whether personal lifestyle and biological factors can predict how a person’s blood sugar responds after meals.
-
Switching to Zenagamtide From Tirzepatide in Adults With Overweight or Obesity With or Without Type 2 Diabetes
This study tests whether adults who are overweight or have obesity (with or without type 2 diabetes) can switch from tirzepatide to a new treatment called zenagamtide to find a tolerable dose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.