Heat Therapy for Type 2 Diabetes

Overseen By Bruno Tesini Roseguini, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Purdue University

Disqualifiers: Type 1 diabetes, Cardiovascular events, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is heat therapy generally safe for humans?

Heat therapy, including methods like hyperthermia, is generally considered safe for humans, with mild side effects such as temporary skin changes. However, higher temperatures can increase the risk of thermal toxicity, so careful monitoring is important. ^{1 2 3 4 5}

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

Heat therapy for type 2 diabetes is unique because it involves using hot water or saunas to improve blood sugar control, similar to the benefits of exercise. Unlike traditional medications, it works by potentially enhancing insulin sensitivity and promoting vascular health through increased heat exposure. ^{6 7 8 9 10}

What is the purpose of this trial?

This study aims to test whether home-based heat therapy (HT) can improve the health of older adults with type 2 diabetes (T2D). T2D is common in older adults and can lead to severe issues such as heart disease, disability, and early death. While regular exercise is known to help manage T2D, many people with the condition find it difficult to stay active. This study explores HT as a simple, non-invasive treatment that may offer similar benefits. Participants will wear special leg sleeves that deliver heat to their legs for 90 minutes each day at home over 12 weeks. The study\'s primary goal is to assess whether HT treatment at home is feasible and safe to use. We hypotesize that people with diabetes who receive heat therapy will have better blood sugar control, stronger legs, less body fat, and improved ability to walk, along with lower blood pressure. If successful, HT could offer a new option for people with T2D to manage their condition, especially for those who struggle with regular exercise. This research could lead to larger studies and help provide a practical way to improve health and quality of life for older adults with diabetes.

Eligibility Criteria

This trial is for older adults with type 2 diabetes who may have difficulty engaging in regular exercise. The study will test if heat therapy can be a safe, home-based treatment to help manage their condition.

Inclusion Criteria

I am 55 years old or older.

I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

I have heart problems like chest pain or heart failure.

Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >110 mmHg)

I have Type 1 Diabetes and need insulin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-based heat therapy using leg sleeves for 90 minutes daily

12 weeks

Weekly phone calls for safety monitoring

Follow-up

Participants are monitored for changes in health-related quality of life, insulin sensitivity, and physical performance

4 weeks

Treatment Details

Interventions

• Heat Therapy

Trial Overview Participants will use special leg sleeves that provide heat for 90 minutes daily over 12 weeks at home. The study aims to see if this improves blood sugar control, muscle strength, body composition, walking ability, and lowers blood pressure.

Participant Groups

Group I: HEAT THERAPY Experimental Treatment 1 Intervention

In the leg heat therapy group, water at 42ºC will be circulated through the leg sleeves.

Group II: SHAM Placebo Group 1 Intervention

In the sham group, water at 33ºC will be circulated through the leg sleeves.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Findings from Research

A study involving 22 adult participants showed that a digital heating device significantly increased transepidermal water loss immediately after treatment, indicating temporary changes to skin parameters, but these changes were not sustained at follow-up.

The device also led to a notable 38.6% decrease in subjective anxiety immediately after treatment, suggesting potential benefits for mood, although these effects were not significant at the follow-up visit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Pulsing Digital Heating Devices on Skin Parameters, Subjective Pain, Mood, and Anxiety. Natarelli, N., Subramanyam, C., Gahoonia, N., et al.[2023]

In a systematic review of 22 studies involving 2330 patients with recurrent breast cancer, higher doses of hyperthermia therapy (HT) significantly improved clinical outcomes, including a 34% increase in complete responses compared to lower doses.

While higher thermal doses during HT enhanced treatment effectiveness, they also raised the risk of thermal toxicity, indicating a need for careful balance in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temperature and thermal dose during radiotherapy and hyperthermia for recurrent breast cancer are related to clinical outcome and thermal toxicity: a systematic review. Bakker, A., van der Zee, J., van Tienhoven, G., et al.[2020]

High-temperature hyperthermia is an effective method for destroying cancerous tissue and reducing benign tumors, offering a minimally-invasive alternative to traditional surgery with lower risks of complications.

The review highlights various heating technologies, such as RF, microwave, ultrasound, and laser, emphasizing the need for advancements in spatial accuracy and image-guidance to improve treatment outcomes in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal ablation and high-temperature thermal therapy: overview of technology and clinical implementation. Diederich, CJ.[2023]

Hyperthermia, a heat therapy that raises body temperature, can be used alone or in combination with treatments like chemotherapy and radiotherapy to enhance therapeutic effects against cancer.

The paper reviews various heating methods and devices, highlighting the mechanisms of heat-induced cell death and discussing the benefits and risks associated with hyperthermia, as well as future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles, applications, risks and benefits of therapeutic hyperthermia. Habash, RW., Krewski, D., Bansal, R., et al.[2022]

In a study involving 10 breast cancer patients, hyperthermia combined with chemotherapy (including AC, paclitaxel, S-1, and aromatase inhibitors) showed promising efficacy, with two patients experiencing a partial response to treatment.

The treatment was generally well-tolerated, with only mild toxicity observed (grade 1 acute skin toxicity), suggesting that hyperthermia could be a safe addition to breast cancer therapy, although further research with a larger patient group is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Local Microwave Hyperthermia for Advanced or Recurrent Breast Cancer]. Yamamoto, C., Yamamoto, D., Tsubota, Y., et al.[2015]

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]

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]

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]

The HEATED Study is a randomized controlled trial investigating the effects of heat therapy using natural thermal mineral water on glycaemic control in patients with type 2 diabetes mellitus, involving 130 participants over 12 weeks.

The primary outcome will measure changes in glycated hemoglobin levels, which is a key indicator of blood sugar control, to determine the efficacy of heat therapy compared to thermoneutral water baths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of HEAT therapy in patiEnts with type 2 Diabetes mellitus (HEATED): protocol for a randomised controlled trial. Sebők, J., Édel, Z., Dembrovszky, F., et al.[2022]

Regular thermal therapy, such as using saunas or hot baths, can improve insulin sensitivity and enhance nitric oxide production, which are beneficial for vascular health, similar to the effects of aerobic exercise.

Thermal therapy may serve as a practical alternative for individuals unable to engage in regular exercise, potentially aiding in diabetic control and lowering blood pressure in conditions like hypertension and heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regular thermal therapy may promote insulin sensitivity while boosting expression of endothelial nitric oxide synthase--effects comparable to those of exercise training. McCarty, MF., Barroso-Aranda, J., Contreras, F.[2009]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Pulsing Digital Heating Devices on Skin Parameters, Subjective Pain, Mood, and Anxiety. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Temperature and thermal dose during radiotherapy and hyperthermia for recurrent breast cancer are related to clinical outcome and thermal toxicity: a systematic review. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Thermal ablation and high-temperature thermal therapy: overview of technology and clinical implementation. [2023]

4. Singapore pubmed.ncbi.nlm.nih.gov

Principles, applications, risks and benefits of therapeutic hyperthermia. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[Local Microwave Hyperthermia for Advanced or Recurrent Breast Cancer]. [2015]

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

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

7. 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]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Effect of HEAT therapy in patiEnts with type 2 Diabetes mellitus (HEATED): protocol for a randomised controlled trial. [2022]

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

Regular thermal therapy may promote insulin sensitivity while boosting expression of endothelial nitric oxide synthase--effects comparable to those of exercise training. [2009]