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Behavioural Intervention
Heat Therapy for Type 2 Diabetes
Phase 1
Recruiting
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 55 and older
Diagnosed with 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%)
Must not have
Symptomatic coronary artery disease and/or heart failure
Insulin-dependent Type 1 Diabetes Mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-week follow-up
Summary
This trial aims to test if using heat therapy at home can help improve the health of older adults with type 2 diabetes. The study will have participants wear special leg sleeves that deliver heat to their legs
Who is the study for?
This trial is for older adults with type 2 diabetes who may have difficulty engaging in regular exercise. The study will test if heat therapy can be a safe, home-based treatment to help manage their condition.
What is being tested?
Participants will use special leg sleeves that provide heat for 90 minutes daily over 12 weeks at home. The study aims to see if this improves blood sugar control, muscle strength, body composition, walking ability, and lowers blood pressure.
What are the potential side effects?
Potential side effects of the heat therapy could include skin irritation or burns from the leg sleeves and discomfort due to prolonged heat exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
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I have been diagnosed with Type 2 Diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart problems like chest pain or heart failure.
Select...
I have Type 1 Diabetes and need insulin.
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I have not had a heart attack or stroke in the past year.
Select...
My cancer is currently active.
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I have bone issues that prevent me from doing physical tests.
Select...
I cannot wear water-circulating garments.
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I use a walking aid that is not a cane.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12-week follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completion rate
Compliance
Safety
Secondary study objectives
Change in 6-minute walk distance
Change in Insulin sensitivity
Change in Short Physical Performance Battery (SPPB) score
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HEAT THERAPYExperimental Treatment1 Intervention
In the leg heat therapy group, water at 42ºC will be circulated through the leg sleeves.
Group II: SHAMPlacebo Group1 Intervention
In the sham group, water at 33ºC will be circulated through the leg sleeves.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heat therapy
2013
N/A
~300
Find a Location
Who is running the clinical trial?
Purdue UniversityLead Sponsor
233 Previous Clinical Trials
71,349 Total Patients Enrolled