Home-based Heat Therapy for Type 2 Diabetes

NCT05269589 | Recruiting

• 1 other identifier: 2021-2959
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C (HbA1C)

  Change from baseline to 12 weeks

Secondary Outcomes (7)

• Insulin resistance (HOMA-IR)

  Change from baseline to 12 weeks

• Postprandial metabolism following meal

  Change from baseline to 12 weeks

• Peripheral endothelial function

  Change from baseline to 12 weeks

• Post-occlusion reactive hyperemia

  Change from baseline to 12 weeks

• Ischemic handgrip exercise

  Change from baseline to 12 weeks

Study Arms (2)

Thermoneutral

SHAM COMPARATOR

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

Other: Thermoneutral water

Heat

EXPERIMENTAL

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

Other: Hot water

Interventions

Thermoneutral water OTHER

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

Thermoneutral

Hot water OTHER

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

Heat

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75 years
• Diagnosis of type 2 diabetes mellitus ≥1 year
• Stable medication ≥12 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Centre ÉPIC, Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Daniel Gagnon, PhD

CONTACT

514-374-1480; daniel.gagnon.3@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 8, 2022
• Study Start: February 18, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)