Home-based Heat Therapy for Type 2 Diabetes

Sponsor
Montreal Heart Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05269589
Collaborator
(none)
44
1
2
26.4
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Thermoneutral water
  • Other: Hot water
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults With Type 2 Diabetes
Actual Study Start Date :
Feb 18, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Thermoneutral

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

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

Experimental: Heat

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

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

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1C (HbA1C) [Change from baseline to 12 weeks]

Secondary Outcome Measures

  1. Insulin resistance (HOMA-IR) [Change from baseline to 12 weeks]

  2. Postprandial metabolism following meal [Change from baseline to 12 weeks]

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

  3. Peripheral endothelial function [Change from baseline to 12 weeks]

    Brachial artery flow-mediated dilation

  4. Post-occlusion reactive hyperemia [Change from baseline to 12 weeks]

    Reactive hyperemia following 5 minutes of forearm ischemia

  5. Ischemic handgrip exercise [Change from baseline to 12 weeks]

    Reactive hyperemia following ischemic handgrip exercise

  6. Arterial stiffness [Change from baseline to 12 weeks]

    Carotid-femoral pulse wave velocity

  7. Blood pressure [Change from baseline to 12 weeks]

    24-hour ambulatory blood pressure monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre ÉPIC, Montreal Heart Institute Montréal Quebec Canada H1T1N6

Sponsors and Collaborators

  • Montreal Heart Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Gagnon, Principal Investigator, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT05269589
Other Study ID Numbers:
  • 2021-2959
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022