An interventional study of Cold exposure with shivering in Type 2 Diabetes, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science
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.
In a longitudinal design, participants will be exposed to a 10-day cold acclimation with daily shivering. Several metabolic read-out parameters will be evaluated before, during and after the intervention.
On their first visit (Visit 1) participants will arrive to the research facility to receive a physical activity, ambulatory blood pressure and continuous glucose monitors. Around 48 hours following Visit 1, participants will return (Visit 2) for the baseline two-step hyperinsulinaemic-euglycaemic clamp (HEC) measurement, used to assess their hepatic and peripheral insulin sensitivity. Within 1 week after Visit 2 the acclimation period with 10 consecutive daily shivering sessions will start (Visits 3 - 12). During the first (Visit 3) and last (Visit 12) cold exposure sessions organ-specific fatty acid uptake, and oxidative vs. non-oxidative metabolism will be determined using [11C]-palmitate PET/CT. Additionally, indirect calorimetry and regular blood sampling will be performed. During cold exposures 2 to 9, heat loss will be assessed by measuring change in water temperature perfused through the cold exposure suit. In addition, skin temperature, as well as surface electromyography and blood pressure measurements will be performed on days 3, 5, 7 and 9 (Visits 5, 7, 9 and 11) during the acclimation period. On the last cold exposure day participants will be provided a standard dinner to be consumed in the evening before Visit 13. Around 16h following Visit 12, i.e. the day after, participant will return for the post-intervention HEC (Visit 13). At the end of Visit 13, participants will be supplied with an activity and ABP monitors for the post-intervention measuremends. Finally, participants will return to the research centre \~42-45h after Visit 13 for the close-out visit (Visit 14) during which the two monitors will be collected.
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This study's planned enrollment of 15 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
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.
Behavioral: Cold exposure with shivering
Cold exposure which elicits a minimally 80% increase in the baseline metabolic rate of participants.
Whole-body insulin sensitivity measured as glucose infusion rate (GIR) in µmol/kg/min during the stable period of the low- and high-insulin phase of the clamp.
1\) Hepatic insulin sensitivity measured as percent EGP suppression in µmol/kg/min; 2) Peripheral insulin sensitivity measured as Rd in µmol/kg/min. Determined by means of a hyperinsulinaemic-euglycaemic clamp.
Time frame: At baseline and Day 13.
11-C palmitate uptake and oxidation in liver and skeletal muscle, expressed in µmol/g/min
Determined by means of PET-CT scanning with a cervico-thoracic dynamic acquisition with 1-\[11C\]-palmitate (175 MBq).
Time frame: At Day 3 and Day 12.
24-hour systolic and diastolic blood pressure and heart rate
24-hour ambulatory blood pressure before and after the 10-day cold acclimation
Time frame: 24-hour period before the baseline clamp (i.e. visit 2) and 24-hour period after the post-acclimation clamp (i.e. visit 13).
Plasma metabolites
1. In the fasted state plasma metabolites such as glucose, insulin, free fatty acids, triglycerides, inflammatory markers, liver enzymes, etc. will be measured 2. Under cold- and insulin-stimulated conditions circulating metabolites and hormones during the first and last cold exposure, as well as during the hyperinsulinaemic euglycaemic clamp will be measured
Time frame: Day 2 and Day 13 for insulin stimulated conditions, and Day 3 and Day 12 for cold-stimulated conditions.
Average 24-hour interstitial glucose concentrations
24-hour interstitial glucose values measured under normal living conditions via continuous glucose monitors
Time frame: 24-hour period before Day 2 and after Day 13.
Energy expenditure
Energy expenditure will be assessed via indirect calorimetry before and after the 10-day acclimation during: * Baseline (room temperature) * Cold exposure * Baseline phase of the hyperinsulinaemic euglycaemic clamp * Low- and high-insulin phase of the hyperinsulinaemic euglycaemic clamp
Time frame: During hyperinsulinaemic euglycaemic clamp: at baseline and day 13 During cold exposure: Day 3 and Day 12
Substrate (CHO and fat) oxidation
CHO and fat oxidation will be assessed via indirect calorimetry before and after the 10-day acclimation during: * Baseline (room temperature) * Cold exposure - Baseline phase of the hyperinsulinaemic euglycaemic clamp * Low- and high-insulin phase of the hyperinsulinaemic euglycaemic clamp
Time frame: During hyperinsulinaemic euglycaemic clamp: at baseline and day 13 During cold exposure: Day 3 and Day 12
Skin temperature
Skin temperature will be assessed via skin thermistors attached to 12 different locations around the body
Time frame: Day 3, Day 5, Day 7, Day 9, Day 11 and Day 12
Shivering intensity
Muscle activity at baseline and during cold exposure will be assessed via electromyography sensors placed on up to 8 different muscle groups.
Time frame: Day 3, Day 5, Day 7, Day 9, Day 11 and Day 12
Morning blood pressure
Systolic and diastolic blood pressure will be assessed by means of an automated office blood pressure device.
Time frame: Day 3, Day 5, Day 7, Day 9, Day 11 and Day 12
Morning heart rate
Morning heart rate will be assessed by means of an automated office blood pressure device.
Time frame: Day 3, Day 5, Day 7, Day 9, Day 11 and Day 12
Plan to share: Yes — IPD from published manuscript will be provided upon reasonable request and dependent upon specific permission from the Comité d'éthique de la recherche du CIUSSS de l'Estrie-CHUS. In addition, the study protocol, statistical analysis plan and informed consent form may also be available upon reasonable request and approval from the Comité d'ethique de la recherche du CIUSSS de l'Estrie-CHUS.
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Université de Sherbrooke