Postprandial HyperglycemiaNCT04232098
Effect of Feet and Calf Heating on Glucose Tolerance
A study testing Heat to ankle and Heat to calf in people with Postprandial Hyperglycemia and Heart Rate Variability, run by San Diego State University at 1 site in United States.
Trial summary
Determine the effect of feet and calf heating on glucose tolerance relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Heart Rate Variability
- What is being tested?
- Heat to ankle and Heat to calf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anyone within specified age range
Who cannot join
- Anyone outside specified age range
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92115
About this study
Determine the effect of feet and calf heating on glucose tolerance relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius).
- Conditions
- Postprandial Hyperglycemia, Heart Rate Variability
- Being tested
- Heat to ankle, Heat to calf
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat to ankleOther
Heat administered via hot water to ankle level
Heat to calfOther
Heat administered via hot water to calf level
| Study group | Role | What they receive |
|---|---|---|
| Thermoneutral | No intervention | thermoneutral condition |
| Feet heated | Experimental | Hot water up to ankles Receives: Other: Heat to ankle |
| Calf heated | Experimental | Hot water up to top of calves Receives: Other: Heat to calf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measured: 30 minute
Blood Glucose
Measured: 60 minute
Blood Glucose
Measured: 90 minute
Blood Glucose
Measured: 120 minute
Secondary outcomes (8)
Blood Pressure
Measured: 30 min
Blood Pressure
Measured: 60 min
Blood Pressure
Measured: 90 min
Blood Pressure
Measured: 120 min
Tympanic Temperature
Measured: 30 min
Tympanic Temperature
Measured: 60 min
Tympanic Temperature
Measured: 90 min
Tympanic Temperature
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Moore, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232098
- Sponsor's protocol ID
- FEETHEAT
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feet and Calf Heating on Glucose Tolerance
- ClinicalTrials.gov ID
- NCT04232098
- Acronym / sponsor ID
- FEETHEAT
- Conditions
- Postprandial Hyperglycemia, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Jan 2020 (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.
Determine the effect of feet and calf heating on glucose tolerance relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thermoneutral | No intervention | –thermoneutral condition |
| Feet heated | Experimental | Other: Heat to ankleHot water up to ankles |
| Calf heated | Experimental | Other: Heat to calfHot water up to top of calves |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone within specified age range
Key exclusion criteria (1 listed)
- Anyone outside specified age range
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 to ankleHeat administered via hot water to ankle level | Other | Feet heated |
| Heat to calfHeat administered via hot water to calf level | Other | Calf heated |
Primary outcome
Blood Glucose
Time frame: 30 minute
Blood Glucose
Time frame: 60 minute
Blood Glucose
Time frame: 90 minute
Blood Glucose
Time frame: 120 minute
8 secondary outcomes
Blood Pressure
Time frame: 30 min
Blood Pressure
Time frame: 60 min
Blood Pressure
Time frame: 90 min
Blood Pressure
Time frame: 120 min
Tympanic Temperature
Time frame: 30 min
Tympanic Temperature
Time frame: 60 min
Tympanic Temperature
Time frame: 90 min
Tympanic Temperature
Time frame: 120 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 to ankle and Heat to calf in people with Postprandial Hyperglycemia and Heart Rate Variability, run by San Diego State 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Mar 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: 30 minute). The study lists 4 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 20 Mar 2024.