Heat and Exercise in Aging as Therapy (HEAT)

Recruiting now · Not applicable

Conditions studied: Prediabetic State

In brief

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 control in a manner comparable to exercise, specifically High-Intensity Interval Training (HIIT), in older individuals with prediabetes. The study aims to answer the following questions: 1. Does local heat therapy improve muscle architecture (e.g., muscle cross-sectional area, capillary density, mitochondrial content), glucose tolerance, and frailty indicators similarly to HIIT in older individuals with prediabetes? 2. Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?

Key facts

Study ID

NCT06580964

Run by

Texas Tech University

People needed

54

Starts

2025-11-06

Expected to finish

2029-07-31

Last updated by the study team

2026-06-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Texas Tech University — Lubbock, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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