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NCT Number: NCT05269589

Home-based Heat Therapy for Type 2 Diabetes

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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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre ÉPIC, Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location status: Recruiting

Location contact

Daniel Gagnon, PhD

CONTACT

[email protected]

1-514-374-1480 ext. 4205

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: Change from baseline to 12 weeks

Secondary outcomes

  1. Insulin resistance (HOMA-IR)

    Time frame: Change from baseline to 12 weeks

  2. Postprandial metabolism following meal

    Time frame: Change from baseline to 12 weeks

    Quantified over a 6-hour period following the ingestion of a standardized liquid meal

  3. Peripheral endothelial function

    Time frame: Change from baseline to 12 weeks

    Brachial artery flow-mediated dilation

  4. Post-occlusion reactive hyperemia

    Time frame: Change from baseline to 12 weeks

    Reactive hyperemia following 5 minutes of forearm ischemia

  5. Ischemic handgrip exercise

    Time frame: Change from baseline to 12 weeks

    Reactive hyperemia following ischemic handgrip exercise

  6. Arterial stiffness

    Time frame: Change from baseline to 12 weeks

    Carotid-femoral pulse wave velocity

  7. Blood pressure

    Time frame: Change from baseline to 12 weeks

    24-hour ambulatory blood pressure monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Gagnon, PhD

CONTACT

[email protected]

514-374-1480 ext. 4205

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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