Glucose ToleranceHWINCT06193291
Effect of Hot Water Immersion on Heart Rate Variability and Glucose
A study testing Feet heating and Calf heating in people with Glucose Tolerance and HRV, run by San Diego State University at 1 site in United States.
Trial summary
Heat therapy has been shown to reduce risk of various diseases, including heart disease, alzheimers, and pneumonia, as well as all-cause mortality . A previous study found heating a single hand lowers postprandial blood glucose levels with a magnitude similar to certain exercise interventions such as 40 minutes of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance, HRV
- What is being tested?
- Feet heating and Calf heating
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 1 Mar 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
- 18 to 65 years
Who cannot join
- previously diagnosed diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: Effect of Hot Water Immersion on Heart Rate Variability (HRV) and Glucose
Heat therapy has been shown to reduce risk of various diseases, including heart disease, alzheimers, and pneumonia, as well as all-cause mortality . A previous study found heating a single hand lowers postprandial blood glucose levels with a magnitude similar to certain exercise interventions such as 40 minutes of slow walking We propose that heating both feet and heating both legs up to the calves will result in similar glucose reductions in a dose response manner.Overview To determine the effect of heating both feet to the ankles and heating both legs to the calves on postprandial blood glucose
- Conditions
- Glucose Tolerance, HRV
- Being tested
- Feet heating, Calf heating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feet heatingProcedure or surgery
Feet placed in hot water
Calf heatingProcedure or surgery
Feet to calves placed in hot water
| Study group | Role | What they receive |
|---|---|---|
| Thermoneutral | No intervention | Participant sits at room temperature during an oral glucose tolerance test |
| Feet heating | Experimental | Participant sits with feet placed in hot water during an oral glucose tolerance test Receives: Procedure: Feet heating |
| Calf heating | Experimental | Participant sits with legs, up to calves, placed in hot water during an oral glucose tolerance test Receives: Procedure: Calf heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measured: 120 min
Secondary outcomes (1)
Heart rate variability
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 posted5 Jan 2024
- Study start2 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glucose ToleranceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT06193291
- Sponsor's protocol ID
- Hot Water Immersion
- Acronym
- HWI
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laukkanen JA, Laukkanen T, Kunutsor SK. Cardiovascular and Other Health Benefits of Sauna Bathing: A Review of the Evidence. Mayo Clin Proc. 2018 Aug;93(8):1111-1121. doi: 10.1016/j.mayocp.2018.04.008.
PubMed 30077204Kimball AL, McCue PM, Petrie MA, Shields RK. Whole body heat exposure modulates acute glucose metabolism. Int J Hyperthermia. 2018;35(1):644-651. doi: 10.1080/02656736.2018.1516303. Epub 2018 Oct 10.
PubMed 30303421Moore J, Kressler J, Buono MJ. Hand heating lowers postprandial blood glucose concentrations: A double-blind randomized controlled crossover trial. Complement Ther Med. 2020 Mar;49:102280. doi: 10.1016/j.ctim.2019.102280. Epub 2019 Dec 12.
PubMed 32147036
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hot Water Immersion on Heart Rate Variability (HRV) and Glucose
- ClinicalTrials.gov ID
- NCT06193291
- Acronym / sponsor ID
- HWI / Hot Water Immersion
- Conditions
- Glucose Tolerance, HRV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 5 Jan 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.
Heat therapy has been shown to reduce risk of various diseases, including heart disease, alzheimers, and pneumonia, as well as all-cause mortality . A previous study found heating a single hand lowers postprandial blood glucose levels with a magnitude similar to certain exercise interventions such as 40 minutes of slow walking We propose that heating both feet and heating both legs up to the calves will result in similar glucose reductions in a dose response manner.Overview To determine the effect of heating both feet to the ankles and heating both legs to the calves on postprandial blood glucose
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thermoneutral | No intervention | –Participant sits at room temperature during an oral glucose tolerance test |
| Feet heating | Experimental | Procedure: Feet heatingParticipant sits with feet placed in hot water during an oral glucose tolerance test |
| Calf heating | Experimental | Procedure: Calf heatingParticipant sits with legs, up to calves, placed in hot water during an oral glucose tolerance test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 65 years
Key exclusion criteria (1 listed)
- previously diagnosed diabetes
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 |
|---|---|---|
| Feet heatingFeet placed in hot water | Procedure or surgery | Feet heating |
| Calf heatingFeet to calves placed in hot water | Procedure or surgery | Calf heating |
Primary outcome
Blood Glucose
Time frame: 120 min
1 secondary outcome
Heart rate variability
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 8 Jan 2024.
- Background: PubMed 30077204Laukkanen JA, Laukkanen T, Kunutsor SK. Cardiovascular and Other Health Benefits of Sauna Bathing: A Review of the Evidence. Mayo Clin Proc. 2018 Aug;93(8):1111-1121. doi: 10.1016/j.mayocp.2018.04.008.
- Background: PubMed 30303421Kimball AL, McCue PM, Petrie MA, Shields RK. Whole body heat exposure modulates acute glucose metabolism. Int J Hyperthermia. 2018;35(1):644-651. doi: 10.1080/02656736.2018.1516303. Epub 2018 Oct 10.
- Background: PubMed 32147036Moore J, Kressler J, Buono MJ. Hand heating lowers postprandial blood glucose concentrations: A double-blind randomized controlled crossover trial. Complement Ther Med. 2020 Mar;49:102280. doi: 10.1016/j.ctim.2019.102280. Epub 2019 Dec 12.
- 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 Feet heating and Calf heating in people with Glucose Tolerance and HRV, 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 8 Jan 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: 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06193291, which also lists 3 linked publications.
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 8 Jan 2024.