An interventional study of Heat therapy and High-intensity interval training in Prediabetic State, sponsored by Texas Tech University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Texas Tech University · Not applicable, Interventional, and Prevention
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:
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:
Phase 2:
Participants in the HIIT Group will:
Phase 1:
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 54 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Texas Tech University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Heat therapy · Behavioral: High-intensity interval training
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.
Behavioral: Heat therapy · Behavioral: 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.
Behavioral: High-intensity interval training
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 training will be performed 3 days per week for 12 weeks.
Glycemic control
Oral glucose tolerance test (OGTT)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Exercise capacity
VO2peak testing
Time frame: Before intervention, after Phase 1 (at about 12 weeks), and after Phase 2 (at about 24 weeks, except HIIT group)
Anthropometrics 1
Body mass and height to calculate body mass index (BMI)
Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Anthropometrics 2
Waist-to-hip ratio
Time frame: 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)
Time frame: 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
Time frame: Weekly for about 14 (HIIT group) or about 27 (LHT and CON groups) weeks
Plan to share: 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
Supporting information: Study protocol, Analytic code
Time frame: Data associated with each publication will be made available when preprints are available and will continue to be available on the repositories and long as they are supported. Any data that are not yet available by the end of the award period will be made available at that time.
Access criteria: Requests for data must be submitted through the Aging Research Biobank (see https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/).
Data sharing details ↗ · agingresearchbiobank.nia.nih.gov
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jan 2029, 38 months after the start.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 38 months is above that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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