Status:
RECRUITING
Heat and Exercise in Aging as Therapy (HEAT)
Lead Sponsor:
Texas Tech University
Conditions:
Prediabetic State
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The main goal of this two-phase clinical trial is to learn whether local heat therapy, using heat pads applied to the legs, can enhance skeletal muscle health, physical function, and blood sugar contr...
Detailed Description
To achieve the study objectives, researchers will first compare the outcomes of local heat therapy to: 1) HIIT and 2) heat pads set to maintain normal skeletal muscle temperature (control group). Then...
Eligibility Criteria
Inclusion
- Age ≥ 50 years
- Women who are postmenopausal, defined as no menstrual period for at least 12 consecutive months.
- Sedentary (structured exercise \<30 minutes, 3x/week)
- Body weight is at least 110 lbs
- Meet criteria for prediabetes (fasting blood glucose 100-125 mg/dl, hemoglobin A1c 5.7-6.4%)
- Consume \<8 (women) or \<15 (men) alcohol-containing beverages per week
- Do not use nicotine or cannabis
- Not taking any medications that could interfere with responses to the interventions (e.g., corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, metformin, anticoagulants, barbiturates, insulin sensitizers, fibrates, immunosuppressants). If you don't know, that's okay. We'll ask what medications you are on and check whether they fall into one of these categories.
Exclusion
- History of peripheral neuropathies
- Currently taking prescription blood thinners
- Medical complications that could would contraindicate participation in the high intensity interval training (HIIT) intervention including: orthopedic complications that would limit your ability to perform cycling exercise, significant cardiovascular impairments (e.g., history of arrhythmias, severe uncontrolled hypertension, etc.), diagnosed metabolic disease (e.g., diabetes), renal disease, sickle cell anemia, or cancer in remission for \<6 months.
- Known history of slow wound healing
- Lidocaine allergy
- Latex allergy
- Currently pregnant
- \>1.5" subcutaneous fat over the thigh muscle
- Symptoms suggestive of cardiovascular, respiratory, metabolic, or renal diseases including discomfort, pressure, or pain in your chest, neck, jaw, arms, calves, or other areas potentially related to ischemia; shortness of breath at rest or with mild exertion; dizziness or fainting (syncope); difficulty breathing while lying flat (orthopnea) or sudden nighttime breathing difficulties (paroxysmal nocturnal dyspnea); palpitations or rapid heartbeat (tachycardia); pain or cramping in your legs during physical activity (intermittent claudication); a known heart murmur; swelling in your ankles (edema); unusual fatigue or shortness of breath during routine activities or at rest.
Key Trial Info
Start Date :
July 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06580964
Start Date
July 31 2025
End Date
July 1 2029
Last Update
September 17 2025
Active Locations (1)
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1
Texas Tech University
Lubbock, Texas, United States, 79409