RecruitingPhase 1NCT06596967

Heat Therapy in Type 2 Diabetes

Home-based Heat Therapy in Older Adults with Type 2 Diabetes: a Pilot Trial


Sponsor

Purdue University

Enrollment

24 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether heat therapy — wearing a special warming garment — can improve blood sugar control and other health outcomes in older adults with type 2 diabetes who may not be able to exercise vigorously. **You may be eligible if...** - You are 55 years old or older - You have been diagnosed with type 2 diabetes (confirmed by records, medication, or blood sugar levels) **You may NOT be eligible if...** - Your HbA1c (3-month blood sugar average) is below 6.5% or above 9.0% - Your BMI is over 40 kg/m2 - You have type 1 (insulin-dependent) diabetes - You had a heart attack or stroke in the past year - You have symptomatic coronary artery disease or heart failure - You have uncontrolled high or low blood pressure - You need a walking aid other than a cane - You have active cancer, impaired leg sensation, or orthopedic problems that prevent physical testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHeat therapy

Participants will be provided with a heat therapy system comprising a controller unit with a water pump and air pump, a portable heater, and leg sleeves featuring inner-layer water-circulating pads and an outer layer of inflatable bladders. The system is engineered to facilitate effective heat transfer through gentle pneumatic inflation, accommodating various limb dimensions. The heater will be set to warm the water to 42°C. Participants will be instructed to administer the therapy for 90 minutes daily in a seated or supine position.

DEVICESham

Participants will be provided with a heat therapy system comprising a controller unit with a water pump and air pump, a portable heater, and leg sleeves featuring inner-layer water-circulating pads and an outer layer of inflatable bladders. The system is engineered to facilitate effective heat transfer through gentle pneumatic inflation, accommodating various limb dimensions. The heater will warm the water to 33°C. Participants will be instructed to administer the therapy for 90 minutes daily in a seated or supine position.


Locations(1)

Purdue University

West Lafayette, Indiana, United States

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NCT06596967


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