Heat Therapy for Type 2 Diabetes

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Montreal Heart Institute

Must not be taking: Insulin

Disqualifiers: Class 3 obesity, Hypertension, Cardiac disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial will investigate if heat therapy can help people with type 2 diabetes. The study will see if regular heat exposure over a few months improves how their bodies handle fats and sugars and if it benefits their blood vessels. This approach is being tested because current medications alone are not enough to reduce their high risk of heart disease. Heat therapy has been found effective in improving glycaemic control in patients with type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication has been stable for at least 12 weeks before joining.

What data supports the effectiveness of the treatment Home-based Heat Therapy for Type 2 Diabetes?

Research shows that heat therapy, like sauna and hot tub use, can reduce glycated hemoglobin levels by 1% in people with type 2 diabetes, indicating potential benefits for managing the condition. ^{1 2 3 4 5}

Is heat therapy safe for people with type 2 diabetes?

Heat therapy, like using saunas or hot tubs, has been studied for its effects on people with type 2 diabetes and other conditions. It generally appears safe, with some studies showing benefits for blood pressure and vascular health, but it can increase heart rate and body temperature. Always consult with a healthcare provider before starting any new treatment. ^{1 2 3 6 7}

How does heat therapy differ from other treatments for type 2 diabetes?

Heat therapy for type 2 diabetes is unique because it involves using heat, such as from saunas or hot tubs, to potentially improve metabolic health and reduce glycated hemoglobin levels. Unlike traditional treatments that focus on medication or lifestyle changes, this therapy uses heat to stimulate heat shock proteins, which may help manage diabetes and its complications. ^{1 2 5 8 9}

Research Team

Eligibility Criteria

This trial is for men and women aged 45-75 with type 2 diabetes diagnosed at least a year ago, who have been on stable medication for the past 12 weeks. It's not suitable for those with severe heart, kidney or lung diseases, very high obesity (Class 3), uncontrolled hypertension, serious nerve or eye damage from diabetes, those using insulin therapy, or with very high blood fat or cholesterol levels.

Inclusion Criteria

I have been diagnosed with type 2 diabetes for at least a year.

My medication has been the same for the last 12 weeks.

I am between 45 and 75 years old.

Exclusion Criteria

My BMI is 40 or higher.

My high blood pressure is not controlled by medication.

I have been diagnosed with heart, kidney, or lung disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of heat therapy to improve cardiometabolic functions

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Home-based Heat Therapy (Behavioural Intervention)

Trial Overview The study is exploring whether sitting in hot water can improve heart health and sugar metabolism in people with type 2 diabetes. Participants will undergo heat therapy sessions over a period of 12 weeks to see if it helps manage fatty acids after eating, improves insulin sensitivity and benefits the lining of their blood vessels.

Participant Groups

Group I: Heat Experimental Treatment 1 Intervention

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

Group II: Thermoneutral Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials

125

Recruited

85,400+

Dr. Jean-Claude Tardif

Montreal Heart Institute

Chief Medical Officer since 2013

MD from Université de Montréal

Mélanie La Couture

Montreal Heart Institute

Chief Executive Officer since 2013

MBA from University of Western Ontario, Engineering degree from Polytechnique Montréal

Findings from Research

Heat therapy, such as sauna and hot tub use, has been shown to significantly reduce key diabetes markers, including a 1% reduction in glycated hemoglobin, making it a promising treatment option for type 2 diabetes.

Mechanistically, heat therapy may improve insulin sensitivity and reduce body weight through increased levels of nitric oxide and heat shock protein 70, suggesting a biological basis for its benefits in metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat shock proteins and heat therapy for type 2 diabetes: pros and cons. Krause, M., Ludwig, MS., Heck, TG., et al.[2022]

In a study involving 13 adults with type 2 diabetes, hot water immersion significantly increased core temperature and heart rate but did not improve insulin sensitivity or other cardiometabolic markers after the treatment.

Despite previous evidence suggesting heat therapy could enhance cardiometabolic health, this study found that acute hot water immersion did not yield beneficial effects on glucose tolerance, blood vessel function, or inflammatory markers in individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effect of passive heat exposure on markers of cardiometabolic function in adults with type 2 diabetes mellitus. Behzadi, P., Ravanelli, N., Gravel, H., et al.[2022]

Thermal biofeedback-assisted autogenic training significantly improved foot temperature and reduced blood pressure to normal levels in a patient with non-insulin-dependent diabetes and vascular disease over 21 treatment sessions.

After the treatment, the patient experienced a complete cessation of intermittent claudication symptoms and an increase in walking distance by about one mile per day, suggesting these therapies may be effective for improving circulation in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal biofeedback in the treatment of intermittent claudication in diabetes: a case study. Saunders, JT., Cox, DJ., Teates, CD., et al.[2019]

In a study of 838 middle-aged and elderly patients with type 2 diabetes, those who bathed in hot water more frequently (more than seven times a week) showed a moderate association with better glycemic control, as indicated by lower hemoglobin A1c (HbA1c) levels.

The analysis suggested that lower frequencies of hot water bathing (four to six times or less than three times a week) were linked to a higher risk of poor glycemic control, highlighting the potential benefits of regular hot water bathing for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Daily Home-Based Hot Water Bathing and Glycemic Control in Ambulatory Japanese Patients with Type 2 Diabetes Mellitus During the COVID-19 Pandemic: A Multicenter Cross-Sectional Study. Kamioka, H., Mori, Y., Horiuchi, T., et al.[2022]

Long-term hot-tub therapy (HTT) for 5 months significantly improved various health markers in diabetic rats, including lipid profiles, antioxidant capacity, and insulin secretion, while also reducing advanced glycation end products (AGEs).

The increase in extracellular heat shock protein (Hsp70) levels due to HTT may help protect proteins from damage, suggesting a potential mechanism for the observed benefits in managing diabetic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of hot-tub therapy on serum Hsp70 level and its benefit on diabetic rats: a preliminary report. Bathaie, SZ., Jafarnejad, A., Hosseinkhani, S., et al.[2022]

Passive heat therapy shows potential benefits for patients with type-2 diabetes mellitus (T2DM), but the changes in key cardiometabolic parameters like hemoglobin A1c and fasting glucose were not statistically significant based on a systematic review of five studies.

The study suggests that while passive heating may help improve glycemic control, more extensive randomized controlled trials with longer durations are necessary to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat therapy shows benefit in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Sebők, J., Édel, Z., Váncsa, S., et al.[2022]

Heat therapy significantly reduces mean arterial, systolic, and diastolic blood pressure, as shown in a systematic review of 15 studies involving various healthy and clinical populations.

In addition to lowering blood pressure, heat therapy improves vascular function, indicated by enhanced flow-mediated dilatation, suggesting it could be a valuable tool for preventing and managing cardiovascular disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of heat therapy on blood pressure and peripheral vascular function: A systematic review and meta-analysis. Pizzey, FK., Smith, EC., Ruediger, SL., et al.[2022]

Heat therapy significantly reduces muscle atrophy in diabetic rats, with a 34.3% reduction in muscle atrophy after 3 weeks and 44.1% after 6 weeks, indicating its potential effectiveness in preserving muscle mass in diabetes.

The mechanism of action involves the modulation of specific muscle proteins, as heat therapy increased hypertrophy markers (like AKT and mTOR) and decreased atrophy markers (like CD68 and MAFbx), suggesting a beneficial impact on muscle health in diabetic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of heat therapy on neuromuscular function and muscle atrophy in diabetic rats. AlSabagh, AT., Rao, MS., Renno, WM.[2023]

Acute passive heating before or during an oral glucose tolerance test did not improve blood glucose levels or insulin sensitivity in people with type 2 diabetes, indicating it may not enhance glucose tolerance.

However, passive heating significantly increased levels of extracellular heat shock protein 70 (eHSP70) and total energy expenditure, particularly when applied after glucose ingestion, while also reducing diastolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of acute passive heating on glucose tolerance and blood pressure in people with type 2 diabetes: a randomized, balanced crossover, control trial. James, TJ., Corbett, J., Cummings, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Heat shock proteins and heat therapy for type 2 diabetes: pros and cons. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acute effect of passive heat exposure on markers of cardiometabolic function in adults with type 2 diabetes mellitus. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Thermal biofeedback in the treatment of intermittent claudication in diabetes: a case study. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Association of Daily Home-Based Hot Water Bathing and Glycemic Control in Ambulatory Japanese Patients with Type 2 Diabetes Mellitus During the COVID-19 Pandemic: A Multicenter Cross-Sectional Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of hot-tub therapy on serum Hsp70 level and its benefit on diabetic rats: a preliminary report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Heat therapy shows benefit in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The effect of heat therapy on blood pressure and peripheral vascular function: A systematic review and meta-analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of heat therapy on neuromuscular function and muscle atrophy in diabetic rats. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Timing of acute passive heating on glucose tolerance and blood pressure in people with type 2 diabetes: a randomized, balanced crossover, control trial. [2021]