NCT05269589 Home-based Heat Therapy for Type 2 Diabetes
| NCT ID | NCT05269589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montreal Heart Institute |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2022-02-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2022-02-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05269589 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05269589 currently recruiting?
Yes, NCT05269589 is actively recruiting participants. Contact the research team at daniel.gagnon.3@umontreal.ca for enrollment information.
Where is the NCT05269589 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05269589 clinical trial?
NCT05269589 is sponsored by Montreal Heart Institute. The trial plans to enroll 44 participants.
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