Prediabetic StateHEATNCT06580964
Heat and Exercise in Aging as Therapy (HEAT)
A study testing Heat therapy and High-intensity interval training in people with Prediabetic State, run by Texas Tech University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Heat therapy and High-intensity interval training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University
Lubbock, Texas, 79409
Hui Ying Luk, Ph.D., 806-834-0827, huiying.luk@ttu.edu
Danielle Levitt, Ph.D., 806-834-1830, danielle.levitt@ttu.edu
About this study
Official title: Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy
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:
- 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?
- Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?
Read the 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
- Being tested
- Heat therapy, High-intensity interval training
- Keywords
- Exercise, Heat, Aging, Prediabetes, Skeletal Muscle
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat therapyBehavioural
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).
High-intensity interval trainingBehavioural
High-intensity interval training will be performed 3 days per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Local Heat Therapy | Experimental | 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. Receives: Behavioral: Heat therapy; Behavioral: High-intensity interval training |
| Thermoneutral Therapy | Sham comparator | 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. Receives: Behavioral: Heat therapy; Behavioral: High-intensity interval training |
| High-Intensity Interval Training | Active comparator | 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. Receives: Behavioral: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Oral glucose tolerance test (OGTT)
Measured: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Skeletal muscle architecture 1
Immunohistochemical assessment of muscle fiber cross-sectional area and capillary density
Measured: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Skeletal muscle architecture 2
Assessment of skeletal muscle mitochondrial content
Measured: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Frailty status
Fried's Phenotypic Frailty assessment
Measured: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Exercise capacity
VO2peak testing
Measured: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Secondary outcomes (4)
Anthropometrics 1
Body mass and height to calculate body mass index (BMI)
Measured: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Anthropometrics 2
Waist-to-hip ratio
Measured: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Body composition
Lean versus fat mass assessed by dual-energy x-ray absorptiometry (DEXA)
Measured: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Sleep quality
7-point likert scale
Measured: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start6 Nov 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Ying Luk, PhD; Danielle Levitt, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580964
- Sponsor's protocol ID
- R01AG084597
- Acronym
- HEAT
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All raw data generated from this project will be stored on cloud-based servers at Texas Tech University. Cleaned data in an analysis-ready format will be stored in REDCap and periodically uploaded to repositories. Data of sufficient quality from human participants will be uploaded the Aging Research Biobank to allow others to validate replicate research findings. In alignment with the Data Submission Worksheet for the Aging Research Biobank, the following will be submitted to accompany deidentified data derived from human participants: * Full study protocol * Names and descriptions of data sets * Manual of operations * Annotated data collection forms * Data dictionary * Documentation of calculated variables * Summary of deidentification and crosslinking of study ID with new randomized ID * Any changes made to the protocol over time * Frozen datasets used for the primary publication, when applicable
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy
- ClinicalTrials.gov ID
- NCT06580964
- Acronym / sponsor ID
- HEAT / R01AG084597
- Conditions
- Prediabetic State
- Keywords
- Exercise, Heat, Aging, Prediabetes, Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local Heat Therapy | Experimental | Behavioral: Heat therapy, Behavioral: High-intensity interval trainingPhase 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. |
| Thermoneutral Therapy | Sham comparator | Behavioral: Heat therapy, Behavioral: High-intensity interval trainingPhase 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. |
| High-Intensity Interval Training | Active comparator | Behavioral: High-intensity interval trainingPhase 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat therapyHeat 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). | Behavioural | Local Heat Therapy, Thermoneutral Therapy |
| High-intensity interval trainingHigh-intensity interval training will be performed 3 days per week for 12 weeks. | Behavioural | High-Intensity Interval Training, Local Heat Therapy, Thermoneutral Therapy |
Primary outcome
Glycemic control
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Oral glucose tolerance test (OGTT)
Skeletal muscle architecture 1
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Immunohistochemical assessment of muscle fiber cross-sectional area and capillary density
Skeletal muscle architecture 2
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Assessment of skeletal muscle mitochondrial content
Frailty status
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Fried's Phenotypic Frailty assessment
Exercise capacity
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
VO2peak testing
4 secondary outcomes
Anthropometrics 1
Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Anthropometrics 2
Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Body composition
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Sleep quality
Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. All raw data generated from this project will be stored on cloud-based servers at Texas Tech University. Cleaned data in an analysis-ready format will be stored in REDCap and periodically uploaded to repositories. Data of sufficient quality from human participants will be uploaded the Aging Research Biobank to allow others to validate replicate research findings. In alignment with the Data Submission Worksheet for the Aging Research Biobank, the following will be submitted to accompany deidentified data derived from human participants: * Full study protocol * Names and descriptions of data sets * Manual of operations * Annotated data collection forms * Data dictionary * Documentation of calculated variables * Summary of deidentification and crosslinking of study ID with new randomized ID * Any changes made to the protocol over time * Frozen datasets used for the primary publication, when applicable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Ying Luk, PhD; Danielle Levitt, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat therapy and High-intensity interval training in people with Prediabetic State, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Ying Luk, PhD (8068340827, huiying.luk@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.