Heat Therapy in Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age55+
SponsorPurdue University
About 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 does not accept healthy volunteersQualifiers
age 55 and older
Type 2 Diabetes (documented by chart review, presence of treatment for type 2 Diabetes, fasting plasma glucose equal or greater than 126 mg/dL or A1C equal or greater than 6.5%).
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Heat therapy
DeviceParticipants 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.
Sham
DeviceParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: SHAMSham comparator 1 intervention
Group B: HEAT THERAPYExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Compliance
A built-in timer inside the pump that is inaccessible to participants will provide one assessment of patient compliance with the therapy. Compliance will be determined by dividing the number of hours of HT recorded use by the required hours. In addition, patients in both groups will receive a logbook to record their treatment sessions.
Time frame
From enrollment to the end of treatment at 12 weeks2
Completion rate
Completion rates will be defined as the number of patients attending the follow-up assessments.
Time frame
From enrollment to the end of treatment at 12 weeks3
Safety
The study coordinator will call patients weekly to record the occurrence of symptoms, such as faintness or dizziness after exposure to the therapy, and changes in medical status . Adverse events (AEs) will be tracked throughout the study and used as a surrogate for safety-related outcomes.
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Change in Insulin sensitivity
Insulin sensitivity will be calculated using insulin and glucose responses during the oral glucose tolerance test
Time frame
Baseline and 12-week follow-up2
Change in blood pressure
BP will be measured in triplicate in both arms using an automated monitor (Tango M2, SunTech).
Time frame
Baseline and 12-week follow-up3
Change in body composition
Body composition (fat mass and fat-free mass) will be assessed via dual-energy x-ray absorptiometry (DXA).
Time frame
Baseline and 12-week follow-up4
Change in 6-minute walk distance
Participants will receive standardized instructions and will be asked to walk the greatest distance possible by walking back and forth along a 100-ft corridor for 6 min.
Time frame
Baseline and 12-week follow-upSponsors and contacts
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Source ClinicalTrials.gov