Diabetes Mellitus, Type 2, Heat Exposure
Conditions
Brief summary
Insulin resistance and hyperglycemia predispose individuals with type 2 diabetes mellitus (T2DM) to endothelial dysfunction and a greater risk of cardiovascular diseases (CVD). Increased CVD risk in individuals with T2DM persists despite optimal pharmacological therapy, highlighting the need to identify complementary lifestyle interventions that improve cardiometabolic functions in this population. Evidence from animal models suggests that heat exposure improves metabolic functions. Notably, weekly heat exposure for 16 weeks blunts hyperinsulinemia and hyperglycemia induced by a high fat diet in mice. In parallel, studies in humans have shown that heat exposure improves vascular endothelial function. Based on such findings, it has been suggested that heat therapy may represent an effective lifestyle intervention to improve cardiometabolic functions. However, only 1 study has examined the impact of a heat therapy intervention on individuals with T2DM, demonstrating that 6 weeks of heat exposure reduces fasting plasma glucose and hemoglobin A1C. No study has considered potential vascular benefits of heat therapy in individuals with T2DM. This project will investigate cardiometabolic responses to repeated heat exposure in men and women with T2DM. We will test the hypothesis that 12 weeks of heat therapy improves postprandial fatty acid handling, insulin sensitivity and endothelial function in individuals with T2DM.
Interventions
OTHERHot water
Participants will immerse their feet in a foot bath that contains hot water
OTHERThermoneutral water
Participants will immerse their feet in a foot bath that contains thermoneutral water
Sponsors
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 45-75 years * Diagnosis of type 2 diabetes mellitus ≥1 year * Stable medication ≥12 weeks
Exclusion criteria
* Class 3 obesity * Hypertension not controled by medication * Diagnosis of cardiac, renal and/or pulmonary disease * Diagnosis of severe neuropathy and/or retinopathy * Insulin therapy * Fasting plasma triglycerides \>5.0 mmol/L * Fasting total cholesterol \>7 mmol/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C (HbA1C) | Change from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance (HOMA-IR) | Change from baseline to 12 weeks | — |
| Postprandial metabolism following meal | Change from baseline to 12 weeks | Quantified over a 6-hour period following the ingestion of a standardized liquid meal |
| Peripheral endothelial function | Change from baseline to 12 weeks | Brachial artery flow-mediated dilation |
| Post-occlusion reactive hyperemia | Change from baseline to 12 weeks | Reactive hyperemia following 5 minutes of forearm ischemia |
| Ischemic handgrip exercise | Change from baseline to 12 weeks | Reactive hyperemia following ischemic handgrip exercise |
| Arterial stiffness | Change from baseline to 12 weeks | Carotid-femoral pulse wave velocity |
| Blood pressure | Change from baseline to 12 weeks | 24-hour ambulatory blood pressure monitoring |
Countries
Canada
Contacts
CONTACTDaniel Gagnon, PhD
Outcome results
None listed