NCT06580964

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Texas Tech University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prediabetic State

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-31
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2024-08-30
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States