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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Texas Tech University
RECRUITING
Lubbock
Contact Information
Primary
Hui-Ying Luk, PhD
huiying.luk@ttu.edu
8068340827
Backup
Danielle Levitt, PhD
danielle.levitt@ttu.edu
8068341830
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2029-07
Participants
Target number of participants: 54
Treatments
Experimental: Local Heat Therapy
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.
Sham_comparator: Thermoneutral Therapy
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.
Active_comparator: High-Intensity Interval Training
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.
Related Therapeutic Areas
Sponsors
Leads: Texas Tech University

This content was sourced from clinicaltrials.gov