Home-based Heat Therapy for Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Heat Exposure
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Thermoneutral water
Hot water
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Centre ÉPIC, Montreal Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Thermoneutral
Heat
Arm Description
Participants will immerse their feet in a foot bath with water maintained at 36°C
Participants will immerse their feet in a foot bath with water maintained at 42°C
Outcomes
Primary Outcome Measures
Hemoglobin A1C (HbA1C)
Secondary Outcome Measures
Insulin resistance (HOMA-IR)
Postprandial metabolism following meal
Quantified over a 6-hour period following the ingestion of a standardized liquid meal
Peripheral endothelial function
Brachial artery flow-mediated dilation
Post-occlusion reactive hyperemia
Reactive hyperemia following 5 minutes of forearm ischemia
Ischemic handgrip exercise
Reactive hyperemia following ischemic handgrip exercise
Arterial stiffness
Carotid-femoral pulse wave velocity
Blood pressure
24-hour ambulatory blood pressure monitoring
Full Information
NCT ID
NCT05269589
First Posted
February 7, 2022
Last Updated
December 9, 2022
Sponsor
Montreal Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT05269589
Brief Title
Home-based Heat Therapy for Type 2 Diabetes
Official Title
Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Heat Exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermoneutral
Arm Type
Sham Comparator
Arm Description
Participants will immerse their feet in a foot bath with water maintained at 36°C
Arm Title
Heat
Arm Type
Experimental
Arm Description
Participants will immerse their feet in a foot bath with water maintained at 42°C
Intervention Type
Other
Intervention Name(s)
Thermoneutral water
Intervention Description
Participants will immerse their feet in a foot bath that contains thermoneutral water
Intervention Type
Other
Intervention Name(s)
Hot water
Intervention Description
Participants will immerse their feet in a foot bath that contains hot water
Primary Outcome Measure Information:
Title
Hemoglobin A1C (HbA1C)
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Insulin resistance (HOMA-IR)
Time Frame
Change from baseline to 12 weeks
Title
Postprandial metabolism following meal
Description
Quantified over a 6-hour period following the ingestion of a standardized liquid meal
Time Frame
Change from baseline to 12 weeks
Title
Peripheral endothelial function
Description
Brachial artery flow-mediated dilation
Time Frame
Change from baseline to 12 weeks
Title
Post-occlusion reactive hyperemia
Description
Reactive hyperemia following 5 minutes of forearm ischemia
Time Frame
Change from baseline to 12 weeks
Title
Ischemic handgrip exercise
Description
Reactive hyperemia following ischemic handgrip exercise
Time Frame
Change from baseline to 12 weeks
Title
Arterial stiffness
Description
Carotid-femoral pulse wave velocity
Time Frame
Change from baseline to 12 weeks
Title
Blood pressure
Description
24-hour ambulatory blood pressure monitoring
Time Frame
Change from baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Gagnon, PhD
Phone
514-374-1480
Ext
4205
Email
daniel.gagnon.3@umontreal.ca
Facility Information:
Facility Name
Centre ÉPIC, Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T1N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Gagnon, PhD
Phone
1-514-374-1480
Ext
4205
Email
daniel.gagnon.3@umontreal.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Home-based Heat Therapy for Type 2 Diabetes
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