- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520929
Acute Sauna Session and Glucose Control
The Effects of an Acute Sauna Session on Glucose Control in Individuals at Risk for Metabolic Impairments
The goal of this clinical trial is to examine the effect of a single 40-minute sauna session on glucose control in individuals at risk for metabolic impairments.
Research Questions:
- Can a single sauna session completed before a meal reduce the post-meal blood glucose response?
- Can a single sauna session improve 24-hour glucose control?
Study Design:
Participants will complete two lab visits: one involving a sauna session and one placebo visit (resting condition). Researchers will compare the effects on glucose control using a continuous glucose monitor (CGM).
What Participants Will Do:
Attend a sauna familiarization session Have a CGM sensor placed on the upper arm Visit the lab twice (once for sauna, once for placebo) Consume three standardized meals at home after each session
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Etienne Myette-Cote, PhD
- Phone Number: 9025660756
- Email: emyette-cote@upei.ca
Study Contact Backup
- Name: Romina Babazadeh, MSc
- Phone Number: 9026205034
- Email: rbabazadeh@upei.ca
Study Locations
-
-
Prince Edward Island
-
Charlottetown, Prince Edward Island, Canada, C1A 4P3
- Recruiting
- University of Prince Edward Island
-
Contact:
- Etienne Myette-Cote, PhD
- Phone Number: 9026550756
- Email: emyette-cote@upei.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Are 30-55 years old
Have a body mass index of ≥ 27 kg/m2
Have a waist size >102 cm (men) or >88 cm (women)
Have access to transportation for the 2 experimental visits (e.g., car, public transit, or drop-off).
Are cleared for participation based on the Physical Activity Readiness Questionnaire (PAR-Q+).
Exclusion Criteria:
Take medications that affect blood sugar
Exercise intensely 2+ times/week
Have diabetes, heart issues, low blood sugar or pressure
Are pregnant
Regularly use saunas or other heat therapy 1+ times/week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sauna
Infrared sauna session
|
Infrared sauna session (approximately 165°F; two 20-minute sessions separated by a 5-minute rest outside the sauna)
|
|
Placebo Comparator: Resting control
Seated resting session
|
Seated resting session (45 minutes outside the sauna)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental 2-hour postprandial glucose area under the curve (Breakfast)
Time Frame: 2 hours
|
2-hour postprandial incremental AUC of CGM glucose above baseline, measured after the standardized breakfast consumed 45 minutes following the sauna or resting (control) session.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-hour postprandial glucose area under the curve (Breakfast)
Time Frame: 2 hours
|
2-hour postprandial AUC of CGM glucose above baseline, measured after the standardized breakfast consumed 45 minutes following the sauna or resting (control) session.
|
2 hours
|
|
Incremental 2-hour postprandial glucose area under the curve (Lunch)
Time Frame: 2 hours
|
Incremental 2-hour postprandial AUC of CGM glucose above baseline, measured after the standardized lunch consumed 225 minutes following the sauna or resting (control) session.
|
2 hours
|
|
Incremental 2-hour postprandial glucose area under the curve (Dinner)
Time Frame: 2 hours
|
Incremental 2-hour postprandial AUC of CGM glucose above baseline, measured after the standardized lunch consumed 435 minutes following the sauna or resting (control) session.
|
2 hours
|
|
Incremental 2-hour postprandial glucose area under the curve (Bedtime snack)
Time Frame: 2 hours
|
Incremental 2-hour postprandial AUC of CGM glucose above baseline, measured after the standardized lunch consumed 645 minutes following the sauna or resting (control) session.
|
2 hours
|
|
Average incremental 2-hour postprandial glucose area under the curve (4 meals)
Time Frame: 2 hours
|
Average incremental 2-hour postprandial CGM glucose AUC above baseline, measured after each standardized meal consumed following the sauna or resting (control) session.
The incremental AUC for all four meals will be summed and divided by four to calculate the average incremental postprandial response.
|
2 hours
|
|
Time below range
Time Frame: 24 hours
|
Total time (minutes) during which CGM glucose values remained below 3.9 mmol/L over the 24-hour period following the sauna or resting (control) session.
|
24 hours
|
|
Time above range
Time Frame: 24 hours
|
Total time (minutes) during which CGM glucose values remained above 7.8 mmol/L over the 24-hour period following the sauna or resting (control) session.
|
24 hours
|
|
Time in range
Time Frame: 24 hours
|
Total time (minutes) during which CGM glucose values remained between 3.9 and 7.8 mmol/L over the 24-hour period following the sauna or resting (control) session.
|
24 hours
|
|
Session-induced delta glucose
Time Frame: 45 minutes
|
Change in CGM glucose during the 45-minute sauna or resting (control) session, calculated as the difference between post-session and pre-session values (Δ = post - pre).
|
45 minutes
|
|
Fasting glucose
Time Frame: 15 minutes
|
CGM glucose representing fasting levels the morning after the sauna or resting (control) session, computed as the mean glucose over the 15 minutes preceding the standardized breakfast.
|
15 minutes
|
|
Daily mean glucose
Time Frame: 24 hours
|
CGM glucose average over the 24h period following the sauna or resting (control session).
|
24 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Etienne Myette-Cote, University of Prince Edward Island
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPrinceEdwardIsland
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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