Home-based Heat Therapy for Type 2 Diabetes

NCT05269589 — Not applicable, Recruiting, 44 participants, Montreal Heart Institute

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Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults With Type 2 Diabetes

Registry	NCT05269589
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	44 (Estimated)
Sponsor	Montreal Heart Institute (Other)
Conditions	Diabetes Mellitus, Type 2, Heat Exposure
Interventions	Thermoneutral water, Hot water (Other)
Dates	start 2022-02-18, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2022-03-08, last updated 2026-05-12
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Thermoneutral	Sham comparator	Other: Thermoneutral water	Participants will immerse their feet in a foot bath with water maintained at 36°C
Heat	Experimental	Other: Hot water	Participants will immerse their feet in a foot bath with water maintained at 42°C

Thermoneutral water (Other): Participants will immerse their feet in a foot bath that contains thermoneutral water
Hot water (Other): Participants will immerse their feet in a foot bath that contains hot water

+Outcome measures

Primary outcomes

Hemoglobin A1C (HbA1C) [Change from baseline to 12 weeks]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 45 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Centre ÉPIC, Montreal Heart Institute	Montreal, Quebec	Canada	Recruiting