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Tests heat pads on the legs in older adults with prediabetes

Tests leg heat pads in older adults at risk for type 2 diabetes.

Key facts

Who runs it
Texas Tech University
Where
Lubbock, United StatesSee the site
Trial code
Registry title
Heat and Exercise in Aging as Therapy (HEAT)
Status
Recruiting
People taking part
54 people, planned
Started
6 Nov 2025
Expected to end
31 Jul 2029
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Heat therapy
  • High-intensity interval training
Record updated
23 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for inactive adults aged 50 or older with prediabetes. It tests heat pads on the legs against high-intensity interval exercise.

Age
50 years or older
Sex
All sexes. Women must be postmenopausal (no period for at least 12 months in a row).
Disease stage
Prediabetes: fasting blood glucose 100-125 mg/dl (5.6–6.9 mmol/L) and hemoglobin A1c 5.7-6.4% (39–46 mmol/mol).
Earlier treatment
Cannot be taking medicines that could affect the results, such as corticosteroids, opiates, beta blockers, sulfonylureas, insulin, metformin or anticoagulants. Not taking prescription blood thinners.
Biomarker or test result
Fasting blood glucose 100-125 mg/dl (5.6–6.9 mmol/L) and hemoglobin A1c 5.7-6.4% (39–46 mmol/mol).

Main reasons for not taking part

  • Diabetes or other diagnosed metabolic disease
  • Past nerve damage in the limbs (peripheral neuropathy)
  • Heart or lung problems, or symptoms such as chest pain or shortness of breath
  • Lidocaine or latex allergy
  • Currently pregnant

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Currently taking prescription blood thinners
  • History of peripheral neuropathies
  • 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
  • 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
  • Currently pregnant
  • >1.5" subcutaneous fat over the thigh muscle

Where in United States

  • Texas Tech UniversityLubbock, United StatesContact: Hui Ying Luk, Ph.D.Taking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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?

The 3 groups in the trial

  • Local Heat TherapyTreatment being tested

    Phase 1: Heat pads will be applied to both legs and set to a pre-determined, optimized temperature to raise the intramuscular temperature to 3-4°C above resting. Each heating session will last for 90 min/d, 6d/wk (5 at-home and 1 in-lab) for 12 wks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3.

    Treatment: Heat therapy and High-intensity interval training

  • Thermoneutral TherapySham treatment, for comparison

    Phase 1: Heat pads will be applied to both legs and set to a pre-determined temperature to keep the intramuscular temperature in a thermoneutral state (\~35-37°C). Each heating session will last for 90 min, 7d/wk (6 at-home and 1 in-lab) for 12 weeks. Phase 2: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3.

    Treatment: Heat therapy and High-intensity interval training

  • High-Intensity Interval TrainingExisting treatment, for comparison

    Phase 1: High-intensity interval training will be performed 3 d/wk for 12 wks. Each exercise session will consist of 4 cycling exercise intervals (4 min each) with 3 min active rest between intervals. Interval intensity will progressively increase from 70-75% to 90-95% of VO2peak by the end of week 3. Phase 2: N/A.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy
Plain-language title
Tests heat pads on the legs in older adults with prediabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 June 2026