NCT06193291

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

December 21, 2023

Last Update Submit

January 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    120 min

Secondary Outcomes (1)

  • Heart rate variability

    120 min

Study Arms (3)

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

Procedure: Feet heating

Calf heating

EXPERIMENTAL

Participant sits with legs, up to calves, placed in hot water during an oral glucose tolerance test

Procedure: Calf heating

Interventions

Feet heatingPROCEDURE

Feet placed in hot water

Feet heating
Calf heatingPROCEDURE

Feet to calves placed in hot water

Calf heating

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years

You may not qualify if:

  • previously diagnosed diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (3)

  • 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.

    PMID: 30077204BACKGROUND
  • Kimball 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.

    PMID: 30303421BACKGROUND
  • Moore 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.

    PMID: 32147036BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start

March 2, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations