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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether home-based heat therapy can improve the health of older adults with type 2 diabetes. Participants will wear special leg sleeves that warm their legs for 90 minutes daily over 12 weeks. The researchers aim to determine if this simple treatment can help control blood sugar, strengthen legs, reduce body fat, improve walking, and lower blood pressure. Individuals with type 2 diabetes who struggle with regular exercise might find this trial beneficial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

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.

What prior data suggests that this heat therapy is safe for older adults with type 2 diabetes?

A previous study showed that heat therapy (HT) helped people with type 2 diabetes by improving sugar use and insulin response after 30 hot tub sessions. Another study found that frequent hot baths were linked to better blood sugar control. These studies reported no major safety issues, suggesting that HT is generally safe.

However, this trial is in its early stage, focusing primarily on assessing the treatment's safety. Early-stage trials typically involve a small number of participants to closely monitor any side effects. So far, evidence suggests HT might be a safe option for managing type 2 diabetes, especially for those who struggle with regular exercise. More research is needed to confirm its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about heat therapy for type 2 diabetes because it offers a unique, non-drug approach to managing the condition. Unlike standard treatments that often involve medication like metformin or insulin, heat therapy uses warm water circulated at 42ºC through leg sleeves to potentially improve blood sugar control. This method could be particularly beneficial for patients looking for alternative or complementary therapies, as it may enhance circulation and improve insulin sensitivity without the side effects associated with drugs. Plus, its non-invasive nature makes it an appealing option for those who are unable or unwilling to use traditional medications.

What evidence suggests that heat therapy might be an effective treatment for type 2 diabetes?

Research has shown that heat therapy, which participants in this trial may receive, can benefit people with type 2 diabetes. One study found that heat therapy helps the body manage sugar better and increases insulin sensitivity, crucial for controlling diabetes. Another study revealed that regular heat therapy sessions can lower fasting blood sugar levels and improve how the body processes sugar from food. Evidence also indicates that soaking in hot water can enhance heart health and reduce blood pressure in people with diabetes. These findings suggest that heat therapy could be a helpful tool for managing diabetes, especially for those who find regular exercise challenging. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9277369/

Effect of HEAT therapy in patiEnts with type 2 Diabetes ... They found improvements in whole-body glucose uptake, insulin sensitivity and insulin signalling after 30 times 1-hour hot tub sessions for 8–10 ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2021.2003445

Heat therapy shows benefit in patients with type 2 diabetes ... This study aimed to assess the efficacy of passive heat therapy on glycemic and cardiovascular parameters, and body weight among patients with T2DM.

3. journals.physiology.org journals.physiology.org/doi/full/10.1152/japplphysiol.00396.2024

Improving glycemic control via heat therapy in older adults ... Interventions ranging from 2–10 wk of HT via HWI resulted in reductions in fasting glucose and/or glucose response to an oral glucose tolerance ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0306456524002353

The effect of repeated hot water immersion on vascular ... Emerging evidence suggest that HWI may favourably improve vascular function but data are limited in individual with T2DM. The aim was to investigate whether ...

5. port.ac.uk port.ac.uk/news-events-and-blogs/news/hot-tub-therapy-offers-hope-for-people-with-type-2-diabetes

Hot tub therapy offers hope for people with type 2 diabetes Hot tubs can improve insulin effectiveness, heart health and lower blood pressure in people with type 2 diabetes, new research from the University of ...

6. trialx.com trialx.com/clinical-trials/listings/302544/heat-therapy-in-type-2-diabetes/

Heat Therapy in Type 2 Diabetes The primary outcomes are compliance with the HT regimen, measured by a hidden timer, completion rates, device safety, and usability. AIM 2: Examine the effects ...