Diabetes Mellitus, Type 2NCT05269589
Home-based Heat Therapy for Type 2 Diabetes
A study testing Thermoneutral water and Hot water in people with Diabetes Mellitus, Type 2 and Heat Exposure, run by Montreal Heart Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heat Exposure
- What is being tested?
- Thermoneutral water and Hot water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-75 years
- Diagnosis of type 2 diabetes mellitus ≥1 year
- Stable medication ≥12 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre ÉPIC, Montreal Heart Institute
Montreal, Quebec, H1T1N6
Daniel Gagnon, PhD, 1-514-374-1480 ext. 4205, daniel.gagnon.3@umontreal.ca
About this study
Official title: Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults With Type 2 Diabetes
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
- Being tested
- Thermoneutral water, Hot water
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoneutral waterOther
Participants will immerse their feet in a foot bath that contains thermoneutral water
Hot waterOther
Participants will immerse their feet in a foot bath that contains hot water
| Study group | Role | What they receive |
|---|---|---|
| Thermoneutral | Sham comparator | Participants will immerse their feet in a foot bath with water maintained at 36°C Receives: Other: Thermoneutral water |
| Heat | Experimental | Participants will immerse their feet in a foot bath with water maintained at 42°C Receives: Other: Hot water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1C)
Measured: Change from baseline to 12 weeks
Secondary outcomes (7)
Insulin resistance (HOMA-IR)
Measured: Change from baseline to 12 weeks
Postprandial metabolism following meal
Quantified over a 6-hour period following the ingestion of a standardized liquid meal
Measured: Change from baseline to 12 weeks
Peripheral endothelial function
Brachial artery flow-mediated dilation
Measured: Change from baseline to 12 weeks
Post-occlusion reactive hyperemia
Reactive hyperemia following 5 minutes of forearm ischemia
Measured: Change from baseline to 12 weeks
Ischemic handgrip exercise
Reactive hyperemia following ischemic handgrip exercise
Measured: Change from baseline to 12 weeks
Arterial stiffness
Carotid-femoral pulse wave velocity
Measured: Change from baseline to 12 weeks
Blood pressure
24-hour ambulatory blood pressure monitoring
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start18 Feb 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Gagnon, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269589
- Sponsor's protocol ID
- 2021-2959
- Status last verified
- May 2026
- First submitted
- 7 Feb 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Home-based Heat Therapy Intervention on Markers of Cardiometabolic Function in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05269589
- Acronym / sponsor ID
- 2021-2959
- Conditions
- Diabetes Mellitus, Type 2, Heat Exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermoneutral | Sham comparator | Other: Thermoneutral waterParticipants will immerse their feet in a foot bath with water maintained at 36°C |
| Heat | Experimental | Other: Hot waterParticipants will immerse their feet in a foot bath with water maintained at 42°C |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45-75 years
- Diagnosis of type 2 diabetes mellitus ≥1 year
- Stable medication ≥12 weeks
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermoneutral waterParticipants will immerse their feet in a foot bath that contains thermoneutral water | Other | Thermoneutral |
| Hot waterParticipants will immerse their feet in a foot bath that contains hot water | Other | Heat |
Primary outcome
Hemoglobin A1C (HbA1C)
Time frame: Change from baseline to 12 weeks
7 secondary outcomes
Insulin resistance (HOMA-IR)
Time frame: Change from baseline to 12 weeks
Postprandial metabolism following meal
Time frame: Change from baseline to 12 weeks
Peripheral endothelial function
Time frame: Change from baseline to 12 weeks
Post-occlusion reactive hyperemia
Time frame: Change from baseline to 12 weeks
Ischemic handgrip exercise
Time frame: Change from baseline to 12 weeks
Arterial stiffness
Time frame: Change from baseline to 12 weeks
Blood pressure
Time frame: Change from baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoneutral water and Hot water in people with Diabetes Mellitus, Type 2 and Heat Exposure, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Gagnon, PhD (514-374-1480 ext. 4205, daniel.gagnon.3@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (HbA1C) (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.