Clinical trial NCT06596967: Heat Therapy in Type 2 Diabetes
Official title: Home-based Heat Therapy in Older Adults with Type 2 Diabetes: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: heat therapy
type 2 Diabetes
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39;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.

Detailed description: Our objective in this proposal is to conduct a pilot randomized, sham-controlled trial to establish the feasibility, acceptability, and safety of home-based leg HT for 12 weeks in older individuals with T2D. We will also examine changes in glucose regulation, body composition, blood pressure, skeletal muscle strength, and physical function. Individuals will be asked to apply the treatment daily for 90 min using water-circulating sleeves perfused with warm water Our working hypotheses are that diabetic individuals receiving HT will manifest: 1) improved blood glucose regulation, 2) enhanced leg strength and power, 3) lower body fat content, and 4) improved walking tolerance21 and lower blood pressure.

We propose the following specific aims:

AIM 1: Establish the feasibility of home-based HT for older individuals with T2D. The primary outcomes are compliance with the HT regimen, measured by a hidden timer, completion rates, device safety, and usability.

AIM 2: Examine the effects of HT on blood glucose regulation in older adults with T2D. We will assess the change in glycated hemoglobin (HbA1c) and insulin sensitivity index (Matsuda insulin sensitivity index) between baseline and the 12-week follow-up. Glucose, insulin, and HbA1c will be measured in the Translation Core.

AIM 3: Evaluate the effect of HT on lower-extremity functioning and body composition in older adults with T2D. We will assess changes in walking endurance (6-minute walk distance), leg muscle strength and power (isokinetic dynamometry), lower extremity functioning (Short Physical Performance Battery), and body composition (Dual-energy X-ray absorptiometry).

Eligibility criteria: 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 \&lt;6.5% or \&gt;9.0%, (2) body mass index \&gt; 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 \&gt;150 mmHg and/or diastolic blood pressure \&gt;110 mmHg), (7) hypotension (resting systolic BP \&lt; 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.

Primary outcomes:
measure: Compliance
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Completion rate
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Safety
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Change in Insulin sensitivity
timeFrame: Baseline and 12-week follow-up
measure: Change in blood pressure
timeFrame: Baseline and 12-week follow-up
measure: Change in body composition
timeFrame: Baseline and 12-week follow-up
measure: Change in 6-minute walk distance
timeFrame: Baseline and 12-week follow-up
measure: Change in peak torque of the knee extensors
timeFrame: Baseline to 12-week follow-up
measure: Change in Short Physical Performance Battery (SPPB) score
timeFrame: Baseline and 12-week follow-up
measure: Change in Short-Form (SF)-36 Questionnaire scores
timeFrame: Baseline to 12-week follow-up
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References: