Effect of Feet and Calf Heating on Glucose Tolerance

March 18, 2024 updated by: Jeff Moore, San Diego State University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92115
        • San Diego State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Anyone within specified age range

Exclusion Criteria:

  • Anyone outside specified age range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Thermoneutral
thermoneutral condition
Experimental: Feet heated
Hot water up to ankles
Other: Heat to ankle
Heat administered via hot water to ankle level
Experimental: Calf heated
Hot water up to top of calves
Other: Heat to calf
Heat administered via hot water to calf level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Glucose
Time Frame: 30 minute
30 minute
Blood Glucose
Time Frame: 60 minute
60 minute
Blood Glucose
Time Frame: 90 minute
90 minute
Blood Glucose
Time Frame: 120 minute
120 minute

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: 30 min
30 min
Blood Pressure
Time Frame: 60 min
60 min
Blood Pressure
Time Frame: 90 min
90 min
Blood Pressure
Time Frame: 120 min
120 min
Tympanic Temperature
Time Frame: 30 min
30 min
Tympanic Temperature
Time Frame: 60 min
60 min
Tympanic Temperature
Time Frame: 90 min
90 min
Tympanic Temperature
Time Frame: 120 min
120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

January 11, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEETHEAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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