Clinical trial NCT06580964: Heat and Exercise in Aging as Therapy (HEAT)
Official title: Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetic State
Keywords: Exercise
Heat
Aging
Prediabetes
Skeletal Muscle
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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?

Detailed description: To achieve the study objectives, researchers will first compare the outcomes of local heat therapy to: 1) HIIT and 2) heat pads set to maintain normal skeletal muscle temperature (control group). Then, researchers will compare the outcomes of the local heat therapy and control groups after a subsequent HIIT intervention. This will enable the researchers to assess the effectiveness of local heat therapy (compared to HIIT and preceding HIIT) to improve skeletal muscle health, physical function, blood sugar control.

Study Procedures:

All participants will visit the laboratory over three days at the start of the study for baseline assessments and sample collection.

Participants in the Control (CON) and Local Heat Therapy (LHT) groups will:

Phase 1:

* Use heat pads on both thighs at a pre-determined temperature for 90 minutes daily, 6 days a week (5 days at home and 1 day in the laboratory; 12 laboratory visits) for the first 12 weeks.
* Maintain a log of each heat pad session.
* Visit the laboratory over three days at the end of Phase 1 for follow-up 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* 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.

Primary outcomes:
measure: Glycemic control
timeFrame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
measure: Skeletal muscle architecture 1
timeFrame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
measure: Skeletal muscle architecture 2
timeFrame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
measure: Frailty status
timeFrame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
measure: Exercise capacity
timeFrame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Secondary outcomes:
measure: Anthropometrics 1
timeFrame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
measure: Anthropometrics 2
timeFrame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
measure: Body composition
timeFrame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
measure: Sleep quality
timeFrame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: Texas Tech University
name: Hui-Ying Luk, PhD; Danielle Levitt, PhD
role: PRINCIPAL_INVESTIGATOR
References: