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Heat and Exercise in Aging as Therapy (HEAT)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 36 visits
  • Time periods mentioned: 3 days, 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study Procedures: All participants will visit the laboratory over three days at the start of the study for baseline assessments and sample collection."
  • "Phase 2: * Visit the laboratory three days per week for 12 weeks (a total of 36 visits) for exercise training. * Visit the laboratory over three days at the end of Phase 2 for final assessments and sample collection."
  • "Participants in the HIIT Group will: Phase 1: * Visit the laboratory three days per week for 12 weeks (a total of 36 visits) for exercise training. * Visit the laboratory over three days at the end of Phase 1 for final assessments and sample collection."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether heat pads on the legs can improve muscle health, movement, and blood sugar control as well as short bursts of hard exercise. It also tests whether heat before exercise helps muscles respond better. It is for adults age 50 or older with prediabetes, or blood sugar that is higher than normal but below the diabetes range.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 50 or older.
  • Women must have gone at least 12 months without a period.
  • Do little planned exercise: less than 30 minutes, 3 times a week.
  • Weigh at least 110 pounds.
  • Have prediabetes: fasting blood sugar of 100–125 mg/dL and A1c, a measure of average blood sugar, of 5.7–6.4%.
  • Drink fewer than 8 alcoholic drinks a week for women or fewer than 15 for men.
  • Do not use nicotine or cannabis.
  • Do not take medicines that could affect the study results. The study team will check your medicines.

Who can't join

  • A history of nerve damage outside the brain and spinal cord, or slow wound healing.
  • Currently taking prescription blood thinners.
  • Health problems that make hard exercise unsafe, such as bone or joint problems that limit cycling, serious heart or blood pressure problems, diabetes, kidney disease, sickle cell anemia, or cancer that has been in remission for less than 6 months.
  • An allergy to latex or lidocaine, a numbing medicine.
  • Currently pregnant.
  • More than 1.5 inches of fat under the skin over the thigh muscle.
  • Possible signs of heart or blood flow problems, such as chest or other body pain or pressure, leg cramps during activity, a racing heartbeat, a known heart murmur, or swollen ankles.
  • Other concerning symptoms, such as dizziness, fainting, unusual tiredness, or trouble breathing at rest, with light activity, while lying flat, or suddenly at night.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

TX