Home-based Heat Therapy for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269589
• Other study ID #: 2021-2959
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Montreal Heart Institute
• Contact: Daniel Gagnon, PhD
• Phone: 514-374-1480
• Email: daniel.gagnon.3[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heat Exposure

Intervention

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

Locations

Country	Name	City	State
Canada	Centre ÉPIC, Montreal Heart Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C (HbA1C)		Change from baseline to 12 weeks
Secondary	Insulin resistance (HOMA-IR)		Change from baseline to 12 weeks
Secondary	Postprandial metabolism following meal	Quantified over a 6-hour period following the ingestion of a standardized liquid meal	Change from baseline to 12 weeks
Secondary	Peripheral endothelial function	Brachial artery flow-mediated dilation	Change from baseline to 12 weeks
Secondary	Post-occlusion reactive hyperemia	Reactive hyperemia following 5 minutes of forearm ischemia	Change from baseline to 12 weeks
Secondary	Ischemic handgrip exercise	Reactive hyperemia following ischemic handgrip exercise	Change from baseline to 12 weeks
Secondary	Arterial stiffness	Carotid-femoral pulse wave velocity	Change from baseline to 12 weeks
Secondary	Blood pressure	24-hour ambulatory blood pressure monitoring	Change from baseline to 12 weeks