Heat and Exercise in Aging as Therapy (HEAT) for Prediabetes

This study, called HEAT, is looking at whether applying heat pads to your legs (heat therapy) can help improve muscle health, physical ability, and blood sugar control in older adults with prediabetes. It compares heat therapy to high-intensity interval training (HIIT) and a control group. Researchers want to see if heat therapy works as well as exercise, or if it can even boost the benefits of exercise. You might be able to join if you are at least 50 years old, postmenopausal (if female), generally inactive, weigh at least 110 lbs, and have prediabetes (fasting blood sugar between 100-125 mg/dl or A1c between 5.7-6.4%). The study aims to enroll 54 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 54 participants. It compares local heat therapy to high-intensity interval training (HIIT) and a control group.
What's involved
You will have initial assessments over three days. Depending on your group, you might use heat pads on your legs for 90 minutes, 6 days a week for 12 weeks, with 12 lab visits. You might also participate in exercise training three days a week for 12 weeks, involving 36 lab visits, followed by final assessments.
Compensation
Not stated in the trial record.
Follow-up
Your glycemic control and skeletal muscle architecture will be measured before the intervention, after about 12 weeks, and after about 24 weeks (except for the HIIT group).

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NCT06580964

Heat and Exercise in Aging as Therapy (HEAT)

Recruiting
NAAges 50+InterventionalPrevention
Texas Tech University
~54 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Heat therapyHigh-intensity interval training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycemic control
Measured over Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
+4 more outcomes measured
Prediabetic State
1 sites across 1 states
Texas1
  • Hui-Ying Luk, PhD; Danielle Levitt, PhD · PRINCIPAL_INVESTIGATOR · Texas Tech University

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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.
  • Glycemic controlBefore intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Oral glucose tolerance test (OGTT)

  • Skeletal muscle architecture 1Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Immunohistochemical assessment of muscle fiber cross-sectional area and capillary density

  • Skeletal muscle architecture 2Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Assessment of skeletal muscle mitochondrial content

  • Frailty statusBefore intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    Fried's Phenotypic Frailty assessment

  • Exercise capacityBefore intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)

    VO2peak testing