Home-based Heat Therapy for Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorMontreal Heart Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 45-75 years

Diagnosis of type 2 diabetes mellitus ≥1 year

Stable medication ≥12 weeks

Disqualifiers

Class 3 obesity

Hypertension not controled by medication

Diagnosis of cardiac, renal and/or pulmonary disease

Diagnosis of severe neuropathy and/or retinopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thermoneutral water

    Other intervention

    Participants will immerse their feet in a foot bath that contains thermoneutral water

  • Hot water

    Other intervention

    Participants will immerse their feet in a foot bath that contains hot water

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: ThermoneutralSham comparator 1 intervention
Group B: HeatExperimental treatment 1 intervention

Trial outcomes

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

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

Time frame
Change from baseline to 12 weeks
3

Peripheral endothelial function

Brachial artery flow-mediated dilation

Time frame
Change from baseline to 12 weeks
4

Post-occlusion reactive hyperemia

Reactive hyperemia following 5 minutes of forearm ischemia

Time frame
Change from baseline to 12 weeks

Other outcomes

Sponsors and contacts

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