Recruiting
Phase 1

Heat Therapy

Sponsor:

Purdue University

Code:

NCT06596967

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Heat therapy

Sham

Study Details

Brief 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.

Conditions

Type 2 Diabetes

Study ID

NCT06596967

Start date

Sep 3, 2024

Status verified date

Sep, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age 55 and older
2. 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%).

Exclusion Criteria:

(1) HbA1c \<6.5% or \>9.0%, (2) body mass index \> 40 kg/m2, (3) insulin-dependent Type 1 Diabetes Mellitus, (4) incident cardiovascular events in the last year (heart attack, stroke), (5) symptomatic coronary artery disease and/or heart failure, (6) uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>110 mmHg), (7) hypotension (resting systolic BP \< 90 mmHg), (8) use of walking aid other than a cane, (9) active cancer, (10) impaired thermal sensation in the legs, (11) unable to fit into water-circulating garments, (12) orthopedic complications that preclude completion of physical function tests, (13) contraindications or inability to undergo a DXA scan, including implants, devices, or other foreign material, and inability to attain correct position and/or remain motionless for the measurement.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Heat 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.

Sham

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bruno Tesini Roseguini, PhD

(765) 496-2612brosegui@purdue.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47907

Contacts

Bruno Tesini Roseguini, PhD

(765) 496-2612brosegui@purdue.edu

More Information

Sponsor

Purdue University

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • heat therapy
  • type 2 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2024-09-19.