Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06580964

Heat and Exercise in Aging as Therapy (HEAT)

Sponsor: Texas Tech University

View on ClinicalTrials.gov

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 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?

Official title: Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-31

Completion Date

2029-07

Last Updated

2025-09-17

Healthy Volunteers

Conditions

Prediabetic State

Interventions

BEHAVIORAL

Heat therapy

Heat pads will be set to a pre-determined, optimized temperature and applied to both legs for 90 min, 6d/wk (5 at-home and 1 in-lab).

BEHAVIORAL

High-intensity interval training

High-intensity interval training will be performed 3 days per week for 12 weeks.

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Texas Tech University

Lubbock, Texas, United States