Clinical trial NCT05269589: Home-based Heat Therapy for Type 2 Diabetes
Official title: Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Heat Exposure
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1C (HbA1C)
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Insulin resistance (HOMA-IR)
timeFrame: Change from baseline to 12 weeks
measure: Postprandial metabolism following meal
timeFrame: Change from baseline to 12 weeks
measure: Peripheral endothelial function
timeFrame: Change from baseline to 12 weeks
measure: Post-occlusion reactive hyperemia
timeFrame: Change from baseline to 12 weeks
measure: Ischemic handgrip exercise
timeFrame: Change from baseline to 12 weeks
measure: Arterial stiffness
timeFrame: Change from baseline to 12 weeks
measure: Blood pressure
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre ÉPIC, Montreal Heart Institute
state: Quebec
Study officials:
References: