Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT07573917

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

Led by Université de Sherbrooke · Updated on 2026-05-07

15

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

U

Université de Sherbrooke

Lead Sponsor

M

Maastricht University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients able to provide signed and dated written informed consent
  • Women are post-menopausal (at least 1 year after last menstrual period)
  • Age between 40 and 75 years
  • Suitable veins for cannulation or repeated blood draws
  • Body mass index (BMI) between 25 and 38 kg/m2
  • Stable diet with no weight change over 5 kg in past 3 months
  • Diagnosed with Type 2 Diabetes for at least 1.5 years
  • Relatively well-controlled diabetes with HbA1c below 8.5%
  • Taking metformin alone or with sulfonylurea and/or stable dose of DPPIV inhibitor for at least 3 months
  • No active diabetes-related complications such as cardiovascular disease, diabetic foot, polyneuropathy, or retinopathy
  • No active liver or kidney problems
Not Eligible

You will not qualify if you...

  • Enrolled in another clinical trial with investigational product within last 3 months
  • Engaging in moderate to high intensity sports or physical activity more than 3 times per week
  • Regular cold exposure such as daily cold baths, working in refrigerated environments, or cold-water swimming/showering within 1 month
  • Unstable body weight (gain or loss over 5 kg in last 3 months)
  • Alcohol consumption over 2 servings per day for men, over 1 serving per day for women
  • Smoking
  • Insulin-dependent or using SGLT2 inhibitors
  • Congestive heart failure or severe kidney or liver failure
  • Men with hemoglobin below 8.4 mmol/L, women below 7.8 mmol/L
  • Pregnant women
  • Participated in a study involving PET/CT scanning within last year
  • Medical doctor may exclude based on medical history, medication use, and fasting blood tests

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre de recherche du CHUS

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

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Research Team

F

Frédérique Frisch

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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