Heat Therapy in Type 2 Diabetes

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Purdue University
Study ID
NCT06596967
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Heat therapy — DEVICE
    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.
  • Sham — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Sep 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: SHAM
    In the sham group, water at 33ºC will be circulated through the leg sleeves.
  • Experimental: HEAT THERAPY
    In the leg heat therapy group, water at 42ºC will be circulated through the leg sleeves.

Primary Outcome Measure

Compliance [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Purdue UniversityWest LafayetteIndiana47907
Bruno Tesini Roseguini, PhD
[email protected]
(765) 496-2612
Bruno Tesini Roseguini, PhD

Find similar trials in West Lafayette, IN

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Purdue University· West Lafayette, IN

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