Heat Therapy for Prediabetes

(HEAT Trial)

Overseen By Danielle Levitt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hui Ying Luk

Must not be taking: Corticosteroids, Opiates, Benzodiazepines, others

Disqualifiers: Peripheral neuropathies, Blood thinners, Cardiovascular impairments, others

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

Compensation: Varies

Number of Visits: 48

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using heat pads on the legs improves muscle health and blood sugar control as effectively as high-intensity interval training (HIIT) in older individuals with prediabetes. By comparing heat therapy to exercise, researchers aim to determine if heat can mimic or enhance the benefits of exercise. Suitable candidates for this trial are individuals over 50 with prediabetes who lead a mostly inactive lifestyle and are not on certain medications. As an unphased trial, participants can contribute to innovative research that may provide new, non-exercise options for managing prediabetes.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications that could interfere with the study, such as corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, metformin, anticoagulants, barbiturates, insulin sensitizers, and fibrates.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that heat therapy is generally safe for most people, including those with type 2 diabetes. One study found that participants using heat therapy experienced better blood sugar control without major side effects. Another study observed changes in blood pressure, but these were not harmful.

For high-intensity interval training (HIIT), studies have demonstrated its safety for most people, including those with prediabetes. HIIT can enhance heart health and blood sugar levels. It can be tailored to each person’s fitness level, reducing the risk of injury.

Both treatments are well-tolerated, with no serious safety concerns reported in existing studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using heat therapy for prediabetes because it offers a non-invasive way to potentially improve blood sugar regulation. Traditional treatments for prediabetes often include lifestyle changes and medications to enhance insulin sensitivity. However, heat therapy works by raising the muscle temperature, which may mimic some of the beneficial effects of exercise without the physical exertion. High-intensity interval training, another part of the study, is already known for its efficiency in boosting cardiovascular health and improving insulin sensitivity. By comparing heat therapy's effects with other methods, researchers hope to uncover new, accessible ways to manage or even prevent the progression of prediabetes.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that heat therapy, one of the treatments in this trial, might help manage blood sugar levels, particularly in older adults at risk for metabolic issues. Some studies have found benefits for people with type 2 diabetes, but further research is needed to confirm these findings.

In contrast, high-intensity interval training (HIIT), another treatment option in this trial, has consistently demonstrated strong results in improving blood sugar control and heart health. Studies indicate that HIIT ranks among the best exercise methods for managing blood sugar and enhancing overall metabolic health in people with prediabetes. Both treatments in this trial aim to improve muscle health and function, which is crucial for managing prediabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

Hui-Ying Luk, PhD; Danielle Levitt, PhD

Principal Investigator

Texas Tech University

Are You a Good Fit for This Trial?

The HEAT trial is for older individuals who have prediabetes. It's designed to see if applying heat pads to the legs can improve muscle health and blood sugar control, similar to high-intensity exercise.

Inclusion Criteria

Sedentary (structured exercise <30 minutes, 3x/week)

I am 60 years old or older.

Do not use nicotine or cannabis

Exclusion Criteria

I have a history of nerve damage in my hands or feet.

Currently pregnant

I don't have health issues that would stop me from doing intense cycling exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Local Heat Therapy or HIIT

Participants in the Local Heat Therapy group use heat pads on both thighs for 90 minutes daily, 7 days a week for 12 weeks. Participants in the HIIT group perform high-intensity interval training 3 days a week for 12 weeks.

12 weeks

12 laboratory visits for LHT group, 36 visits for HIIT group

Phase 2: High-Intensity Interval Training

All participants perform high-intensity interval training 3 days a week for 12 weeks.

12 weeks

36 laboratory visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heat Therapy
• High-intensity interval training

Trial Overview

This study tests whether leg heat therapy can match or boost the benefits of High-Intensity Interval Training (HIIT) on muscle structure, glucose tolerance, and frailty in older adults with prediabetes.

How Is the Trial Designed?

Group I: Local Heat Therapy Experimental Treatment 2 Interventions

Phase 1: Heat pads will be applied to both legs and set to a pre-determined, optimized temperature to raise the intramuscular temperature to 3-4°C above resting. Each heating session will last for 90 min/d, 6d/wk (5 at-home and 1 in-lab) for 12 wks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3.

Group II: High-Intensity Interval Training Active Control 1 Intervention

Phase 1: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3. Phase 2: N/A.

Group III: Thermoneutral Therapy Placebo Group 2 Interventions

Phase 1: Heat pads will be applied to both legs and set to a pre-determined temperature to keep the intramuscular temperature in a thermoneutral state (\~35-37°C). Each heating session will last for 90 min, 7d/wk (6 at-home and 1 in-lab) for 12 weeks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3.

Who Is Running the Clinical Trial?

Hui Ying Luk

Lead Sponsor

Trials

1

Recruited

50+

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

Published Research Related to This Trial

In a pilot study involving 45 outpatients with moderate depression, hyperthermic baths (HTB) showed a significant reduction in depression severity after 2 weeks, with a mean improvement of 4.3 points on the Hamilton Depression Rating Scale compared to a physical exercise program.

HTB was well-tolerated with no serious adverse events reported, making it a promising and accessible add-on treatment for depression, especially for individuals who may struggle with traditional exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study. Naumann, J., Kruza, I., Denkel, L., et al.[2021]

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]

A 12-week study involving 32 prediabetic male patients showed that high-intensity interval training (HIIT) significantly reduced blood glucose levels compared to continuous endurance training at anaerobic threshold (CETAT).

Both HIIT and continuous endurance training at maximal fat oxidation (CETFAT) improved insulin resistance indices similarly, indicating that exercise intensity and type can effectively influence hormonal changes in prediabetic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval vs. Continuous Endurance Training: Preventive Effects on Hormonal Changes and Physiological Adaptations in Prediabetes Patients. Safarimosavi, S., Mohebbi, H., Rohani, H.[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]

High-Intensity Interval Training (HIIT) significantly improves glycaemic control, aerobic resistance, and body composition in individuals with type 2 diabetes, based on a meta-analysis of 180 studies involving participants aged 18 and older.

Specific types of HIIT, such as Sprint Interval HIIT (SIT-HIIT) and Short Interval HIIT (SI-HIIT), may offer greater benefits for fasting blood glucose levels compared to traditional continuous aerobic training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chronic high-intensity interval training programs on glycaemic control, aerobic resistance, and body composition in type 2 diabetic patients: a meta-analysis. Arrieta-Leandro, MC., Moncada-Jiménez, J., Morales-Scholz, MG., et al.[2023]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Effect of HEAT therapy in patiEnts with type 2 Diabetes ...

Heat therapy has been found effective in improving glycaemic control. However, to date, there is a lack of randomised controlled studies ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39829076

Improving glycemic control via heat therapy in older adults at ...

Our pilot study demonstrated promising results for heat therapy (HT) via hot water immersion in older adults at risk for Alzheimer's disease due to metabolic ...

3.

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.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666667725001576

Non-acute effects of passive heating interventions on ...

Current evidence from RCTs indicates that passive heating interventions may not improve most of the cardiometabolic or vascular health markers.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12131943/

Effect of heat therapy compared with strength training on ...

This study aims to evaluate the effects of resistance training (RT) and HT on HbA1c levels, metabolic and inflammatory profiles, gut microbiota, ...

6.

journals.physiology.org

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

Improving glycemic control via heat therapy in older adults ...

Secondary outcomes of the HT intervention demonstrated significant changes in mean arterial pressure, diastolic blood pressure, and cerebral ...

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/533496

Heat Therapy in Type 2 Diabetes

This study aims to test whether home-based heat therapy (HT) can improve the health of older adults with type 2 diabetes (T2D).