Recruiting

Heat Therapy

Sponsor:

Montreal Heart Institute

Code:

NCT05269589

Conditions

Diabetes Mellitus, Type 2

Heat Exposure

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Thermoneutral water

Hot water

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Heat Exposure

Study ID

NCT05269589

Start date

Feb 18, 2022

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Thermoneutral

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

experimental: Heat

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

Interventions

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

Primary outcome measure

  • Hemoglobin A1C (HbA1C) [ Time Frame: Change from baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Centre ÉPIC, Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T1N6

Contacts

More Information

Sponsor

Montreal Heart Institute

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2026-05-12.