Heat Therapy for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Purdue University
Disqualifiers: Type 1 diabetes, Cardiovascular events, Cancer, others
No Placebo Group
Trial Summary
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.
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.
12345How 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.
678910Eligibility 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.
+10 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HEAT THERAPYExperimental Treatment1 Intervention
In the leg heat therapy group, water at 42ºC will be circulated through the leg sleeves.
Group II: SHAMPlacebo Group1 Intervention
In the sham group, water at 33ºC will be circulated through the leg sleeves.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Purdue UniversityWest Lafayette, IN
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Who Is Running the Clinical Trial?
Purdue UniversityLead Sponsor
References
Effect of Pulsing Digital Heating Devices on Skin Parameters, Subjective Pain, Mood, and Anxiety. [2023]A common pitfall of many conventional heat therapy methods is the propensity to lose heat over time and the need for reheating and reapplication. Pain-relieving digital heating devices are now available that can be held in place on the body via adhesive or magnet and provide pulsed heat. However, the safety of such devices among different ages and skin types must be established. We conducted a prospective, open-label study to assess the effect of three consecutive thirty-minute treatment cycles on skin parameters and pain. Effects on mood and anxiety were secondarily assessed. 22 adult participants (20 female, 2 male; mean 58 ± 17.63 years) were recruited. The participants attended one visit with heating device intervention and a follow-up visit after 7-10 days. A 97% significant increase in transepidermal water loss was observed immediately following intervention (p = 8.04487 × 10-7), although significance was not sustained at follow-up. There was an increase along the red/green axis at 13/14 treatment locations immediately following treatment, although only four locations remained significantly increased at follow-up. Pain non-significantly decreased immediately following treatment (p = 0.057). A 38.6% decrease in subjective anxiety was observed immediately after treatment (p = 0.0139), and scores remained non-significantly reduced at follow-up (19.3% reduction from baseline; p = 0.1397). The heating devices elicit temporary changes to the skin, although the lack of significance at follow-up suggests that the devices can be safely used without long-term changes in skin color or barrier status.
Temperature and thermal dose during radiotherapy and hyperthermia for recurrent breast cancer are related to clinical outcome and thermal toxicity: a systematic review. [2020]Objective: Hyperthermia therapy (HT), heating tumors to 40-45 °C, is a known radiotherapy (RT) and chemotherapy sensitizer. The additional benefit of HT to RT for recurrent breast cancer has been proven in multiple randomized trials. However, published outcome after RT + HT varies widely. We performed a systematic review to investigate whether there is a relationship between achieved HT dose and clinical outcome and thermal toxicity for patients with recurrent breast cancer treated with RT + HT. Method: Four databases, EMBASE, PubMed, Cochrane library and clinicaltrials.gov, were searched with the terms breast, radiotherapy, hyperthermia therapy and their synonyms. Final search was performed on 3 April 2019. Twenty-two articles were included in the systematic review, reporting on 2330 patients with breast cancer treated with RT + HT. Results: Thirty-two HT parameters were tested for a relationship with clinical outcome. In studies reporting a relationship, the relationship was significant for complete response in 10/15 studies, in 10/13 studies for duration of local control, in 2/2 studies for overall survival and in 7/11 studies for thermal toxicity. Patients who received high thermal dose had on average 34% (range 27%-53%) more complete responses than patients who received low thermal dose. Patients who achieved higher HT parameters had increased odds/probability on improved clinical outcome and on thermal toxicity. Conclusion: Temperature and thermal dose during HT had significant influence on complete response, duration of local control, overall survival and thermal toxicity of patients with recurrent breast cancer treated with RT + HT. Higher temperature and thermal dose improved outcome, while higher maximum temperature increased incidence of thermal toxicity.
Thermal ablation and high-temperature thermal therapy: overview of technology and clinical implementation. [2023]High-temperature hyperthermia or thermal therapy is being applied for destruction of cancerous tissue, eradication or reduction of benign tumours and targeted tissue modification and remodelling. Many of these high-temperature technologies provide a minimally-invasive alternative with lower morbidities compared to the traditional surgical procedures. The effects of high-temperature thermal exposure on tissues, examples of heating technology and procedures of clinical practice related to high-temperature thermal therapy are reviewed. This brief review encompasses interstitial, endocavity, intraluminal and external applications of RF, microwave, ultrasound, laser and thermal conduction energy sources. The technology is prevalent and in various levels of advancement, with the move toward more spatially-accurate and controllable heating systems combined with image-guidance and treatment verification warranted, especially for the treatment of cancer.
Principles, applications, risks and benefits of therapeutic hyperthermia. [2022]Hyperthermia as a heat therapy is the procedure of raising the temperature of a part of or the whole body above normal for a certain period of time. Based largely on delivery methods, therapeutic hyperthermia falls under three major categories: local, regional, and whole-body. It may be applied alone or jointly with other modalities such as radiotherapy, chemotherapy, radiochemotherapy, and gene therapy. Because of the individual characteristics of each type of treatment, different types of heating systems have evolved. This paper provides an overview of possible mechanisms of heat-induced cell death and the way heating exerts its beneficial effect. It also discusses various heating devices as well as other modalities used with hyperthermia. The paper concludes with a summary of benefits and risks, obstacles encountered in the treatment process, and future research directions.
[Local Microwave Hyperthermia for Advanced or Recurrent Breast Cancer]. [2015]The purpose of our study was to test the efficacy and toxicity of hyperthermia for treating breast cancer. Ten patients received treatment (AC, paclitaxel, S-1, and aromatase inhibitor) in combination with hyperthermia. The hyperthermia device was a microwave heating device with water loaded and water-cooled waveguides. The temperature was monitored subcutaneously in the skin under the aperture of the waveguide. Two patients had a partial response to treatment with only mild toxicity (grade 1 acute skin toxicity). Therefore, hyperthermia combined with chemotherapy for treating breast cancer seems to be effective and generally tolerable. A larger patient cohort is needed to confirm these results in the future.
Heat shock proteins and heat therapy for type 2 diabetes: pros and cons. [2022]Heat therapy, such as sauna and hot tub, has become an increasingly regular therapeutical practice around the world since several studies have shown benefits of heat therapy in metabolic and cardiovascular diseases. The use of heat therapy in people with type 2 diabetes mellitus revealed a striking reduction of 1% unit in the glycated hemoglobin, suggesting this therapy for the treatment of diabetes. Herein, we shall discuss the use of heat therapy and the mechanisms involved, and suggest a provisional guide for the use of heat therapy in obesity and diabetes.
The effect of hot-tub therapy on serum Hsp70 level and its benefit on diabetic rats: a preliminary report. [2022]To carry out a preliminary study examining the efficacy of long-term hot-tub therapy (HTT) in the improvement of diabetic complications on streptozotocin-induced diabetic rats.
Acute effect of passive heat exposure on markers of cardiometabolic function in adults with type 2 diabetes mellitus. [2022]Heat therapy is a promising strategy to improve cardiometabolic health. This study evaluated the acute physiological responses to hot water immersion in adults with type 2 diabetes mellitus (T2DM). On separate days in randomized order, 13 adults with T2DM [8 males/5 females, 62 ± 12 yr, body mass index (BMI): 30.1 ± 4.6 kg/m2] were immersed in thermoneutral (34°C, 90 min) or hot (41°C, core temperature ≥38.5°C for 60 min) water. Insulin sensitivity was quantified via the minimal oral model during an oral glucose tolerance test (OGTT) performed 60 min after immersion. Brachial artery flow-mediated dilation (FMD) and reactive hyperemia were evaluated before and 40 min after immersion. Blood samples were drawn to quantify protein concentrations and mRNA levels of HSP70 and HSP90, and circulating concentrations of cytokines. Relative to thermoneutral water immersion, hot water immersion increased core temperature (+1.66°C [+1.47, +1.87], P < 0.01), heart rate (+34 beats/min [+24, +44], P < 0.01), antegrade shear rate (+96 s-1 [+57, +134], P < 0.01), and IL-6 (+1.38 pg/mL [+0.31, +2.45], P = 0.01). Hot water immersion did not exert an acute change in insulin sensitivity (-0.3 dL/kg/min/μU/mL [-0.9, +0.2], P = 0.18), FMD (-1.0% [-3.6, +1.6], P = 0.56), peak (+0.36 mL/min/mmHg [-0.71, +1.43], P = 0.64), and total (+0.11 mL/min/mmHg × min [-0.46, +0.68], P = 0.87) reactive hyperemia. There was also no change in eHSP70 (P = 0.64), iHSP70 (P = 0.06), eHSP90 (P = 0.80), iHSP90 (P = 0.51), IL1-RA (P = 0.11), GLP-1 (P = 0.59), and NF-κB (P = 0.56) after hot water immersion. The physiological responses elicited by hot water immersion do not acutely improve markers of cardiometabolic function in adults with T2DM.NEW & NOTEWORTHY Heat therapy has been shown to improve markers of cardiometabolic health in preclinical and clinical studies. However, the effects of heat therapy in individuals with type 2 diabetes mellitus (T2DM) remain understudied. We examined the acute effect of hot water immersion on glucose tolerance, flow-mediated dilation, reactive hyperemia, inflammatory markers, and heat shock proteins in adults with T2DM. Hot water immersion did not acutely improve the markers studied.
Effect of HEAT therapy in patiEnts with type 2 Diabetes mellitus (HEATED): protocol for a randomised controlled trial. [2022]The burden of type 2 diabetes mellitus (T2DM) is increasing worldwide. Heat therapy has been found effective in improving glycaemic control. However, to date, there is a lack of randomised controlled studies investigating the efficacy of heat therapy in T2DM. Therefore, we aim to investigate whether heat therapy with natural thermal mineral water can improve glycaemic control in patients with T2DM.
Regular thermal therapy may promote insulin sensitivity while boosting expression of endothelial nitric oxide synthase--effects comparable to those of exercise training. [2009]Regular thermal therapy, using saunas or hot baths, has the potential to improve impaired insulin sensitivity and boost endothelial expression of the "constitutive" isoform of nitric oxide synthase--effects, analogous to those of aerobic training that should promote vascular health. Previous clinical reports suggest that hot tubs may be beneficial for diabetic control, and that sauna therapy can decrease blood pressure in essential hypertension and provide symptomatic benefit in congestive heart failure. For those who lack ready access to a sauna or communal hot tub, regular hot baths at home may suffice as practical thermal therapy. Thermal therapy might be viewed as an alternative to exercise training in patients too physically impaired for significant aerobic activity.