Status:
RECRUITING
Heat Therapy in Type 2 Diabetes
Lead Sponsor:
Purdue University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
55+ years
Phase:
PHASE1
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 hear...
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 wi...
Eligibility Criteria
Inclusion
- 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%).
Exclusion
- (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.
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06596967
Start Date
September 3 2024
End Date
July 31 2025
Last Update
September 19 2024
Active Locations (1)
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1
Purdue University
West Lafayette, Indiana, United States, 47907