Home-based Heat Therapy for Type 2 Diabetes

University of Montreal

Status: Enrolling

Conditions: Heat Exposure; Diabetes Mellitus, Type 2

Treatments: Other: Hot water; Other: Thermoneutral water

Study type: Interventional

Funder types: Other

Identifiers

NCT05269589

2021-2959

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Thermoneutral

Sham Comparator group

Description:

Participants will immerse their feet in a foot bath with water maintained at 36°C

Treatment:

Other: Thermoneutral water

Heat

Experimental group

Description:

Participants will immerse their feet in a foot bath with water maintained at 42°C

Treatment:

Other: Hot water