Research Center: Department of Health and Kinesiology, Purdue University
Location: 800 W Stadium Ave, West Lafayette, IN 47907, United States
Participants Must be able to attend the research center at Purdue University in West Lafayette, Indiana
Lead Researcher: Dr. Bruno Tesini Roseguini, P.h.D.
IRB: This study has been reviewed and approved by Purdue’s Human Research Protection Program

Are you 55 years old or older with type 2 diabetes (T2D) and want to potentially boost your leg strength and mobility? Join Purdue University’s study on leg heat therapy!

Researchers are testing if daily leg heat therapy for 12 weeks can enhance muscle strength and walking ability in people with type 2 diabetes. This non-invasive, home-based treatment uses water-circulating sleeves to heat your legs, making it easy and practical for anyone. 

Interested? Take the questionnaire to see if you qualify and start your journey to better leg strength and mobility!

To complete this questionnaire, you’ll need to have some diabetes management details on hand, such as recent HbA1c levels. Please have this info ready before you start the questionnaire.

• Participants will receive a new potential treatment for type 2 diabetes at no cost.
• Participants will be compensated up to $500 for participating in this study. Compensation will only be provided to eligible participants who complete the study.
• Participants may experience improvements in type 2 diabetes management as heat therapy (HT) using water-circulating sleeves can be used at home, thereby increasing accessibility. Chronic heat therapy may also provide a direct benefit in increasing exercise tolerance in older people with T2D, thus improving their quality of life.
• Participants will be contributing valuable information that may benefit those with T2D in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.

• Participants must be able to attend the research center at Purdue University in West Lafayette, Indiana
• People aged 55 and older who are diagnosed with type 2 diabetes mellitus
• Must not use insulin
• Must not have type 1 diabetes mellitus
• Must not have had any cardiovascular incident or event (e.g., heart attack, stroke) within the last year
• Must not have had symptomatic coronary artery disease (e.g. chest pain) and/or heart failure
• Must not have uncontrolled hypertension
• Must not be using any walking aid assistance other than a cane
• Must not currently be diagnosed with cancer
• Must not have abnormal thermal sensations in the legs
• Must not have any physical limitations, such as orthopedic complications that could prevent you from completing physical function tests
• Must be able to attend 5 study visits at the research site over approximately 12 weeks

Visit 1 (Approx. 3 hours)

• Medical history and study requirement overview.
• Try on heat therapy garments.
• Blood sample collection and body measurements.
• Sensation, walk, balance, and strength tests.
• Complete health and quality-of-life questionnaires.

Visit 2 (Approx. 3.5 hours)

• Body measurements and DEXA scan.
• IV placement and glucose tolerance test with blood samples.

Visit 3 (Approx. 4 hours)

• Blood vessel health test with ultrasound and blood pressure monitoring.
• Repeat physical function tests (walk, balance, chair stands, leg strength).
• Receive home therapy equipment and instructions.

Phase II (12 weeks, at-home therapy)

• Daily 90-minute leg heat therapy with logbook entries.
• Weekly check-in calls with the study coordinator.

Visit 4 (Approx. 3.5 hours)

• Body measurements and DEXA scan.
• IV placement and glucose tolerance test with blood samples.

Visit 5 (Approx. 4 hours)

• Blood vessel health test with ultrasound and blood pressure monitoring.
• Repeat physical function tests (walk, balance, chair stands, leg strength).

Purdue University
Purdue University is a public research university located in West Lafayette, Indiana, USA. It is known for its strengths in engineering, technology, and agriculture, and is consistently ranked among the top universities in the United States for research and innovation. Purdue has a strong focus on translating research into practical applications that can benefit society. Purdue University and Trialfacts are not affiliated. However, Trialfacts collaborates closely with the research team to facilitate a smooth flow of participant recruitment for this study at Purdue. Trialfacts operates as an advertising company to promote the study, while Purdue will be the organization that takes overall responsibility for eligible participants and addresses any questions or concerns that may arise.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.