Home-based heat therapy for older adults with type 2 diabetes
Home-based Heat Therapy in Older Adults with Type 2 Diabetes: a Pilot Trial
This study is testing whether wearing special heated leg sleeves at home for 90 minutes a day can help older adults with type 2 diabetes improve their blood sugar control and overall health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Purdue University Academic / other |
| Locations | 1 site (West Lafayette, Indiana) |
| Trial ID | NCT06596967 on ClinicalTrials.gov |
What this trial studies
This study tests the feasibility and safety of home-based heat therapy for older adults with type 2 diabetes. Participants will wear special leg sleeves that deliver heat for 90 minutes daily over 12 weeks. The study aims to assess improvements in blood sugar control, leg strength, body composition, and physical function. It will also evaluate the acceptability of this non-invasive treatment approach for managing diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with documented type 2 diabetes.
Not a fit: Patients with poorly controlled diabetes, significant cardiovascular issues, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new, accessible way for older adults with type 2 diabetes to manage their condition effectively.
How similar studies have performed: While the specific approach of home-based heat therapy is novel, similar studies exploring non-invasive treatments for diabetes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 \<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.
Where this trial is running
West Lafayette, Indiana
- Purdue University — West Lafayette, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Bruno Tesini Roseguini, PhD
- Email: brosegui@purdue.edu
- Phone: (765) 496-2612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.