Home-based Heat Therapy for Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Heat Exposure
• Interventions: Other: Hot water; Other: Thermoneutral water

• Registration Number: NCT05269589
• Lead Sponsor: Montreal Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-07
• Study Start: 2022-02-18
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heat	Hot water	Participants will immerse their feet in a foot bath with water maintained at 42°C
Thermoneutral	Thermoneutral water	Participants will immerse their feet in a foot bath with water maintained at 36°C

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C (HbA1C)	Change from baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Postprandial metabolism following meal	Change from baseline to 12 weeks	Quantified over a 6-hour period following the ingestion of a standardized liquid meal
Post-occlusion reactive hyperemia	Change from baseline to 12 weeks	Reactive hyperemia following 5 minutes of forearm ischemia
Arterial stiffness	Change from baseline to 12 weeks	Carotid-femoral pulse wave velocity
Insulin resistance (HOMA-IR)	Change from baseline to 12 weeks
Peripheral endothelial function	Change from baseline to 12 weeks	Brachial artery flow-mediated dilation
Ischemic handgrip exercise	Change from baseline to 12 weeks	Reactive hyperemia following ischemic handgrip exercise
Blood pressure	Change from baseline to 12 weeks	24-hour ambulatory blood pressure monitoring

Trial Locations

Locations (1)

Centre ÉPIC, Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada