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Home-based Heat Therapy for Type 2 Diabetes

NCT ID: NCT05269589

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-18

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Heat Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thermoneutral

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

Group Type SHAM_COMPARATOR

Thermoneutral water

Intervention Type OTHER

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

Heat

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

Group Type EXPERIMENTAL

Hot water

Intervention Type OTHER

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

Interventions

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Thermoneutral water

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

Intervention Type OTHER

Hot water

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montreal Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Daniel Gagnon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre ÉPIC, Montreal Heart Institute

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Daniel Gagnon, PhD

Role: CONTACT

Phone: 514-374-1480

Email: [email protected]

Facility Contacts

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Daniel Gagnon, PhD

Role: primary

Other Identifiers

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2021-2959

Identifier Type: -

Identifier Source: org_study_id