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CompletedNCT04232098Updated Mar 20, 2024

Effect of Feet and Calf Heating on Glucose Tolerance

An interventional study of Heat to ankle and Heat to calf in Postprandial Hyperglycemia and Heart Rate Variability, sponsored by San Diego State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by San Diego State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Postprandial Hyperglycemia
  • Heart Rate Variability

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03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's enrollment of 30 is below the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Anyone within specified age range

Exclusion criteria

Exclusion Criteria:

  • Anyone outside specified age range
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Thermoneutral

    thermoneutral condition

  • Experimental
    Feet heated

    Hot water up to ankles

    Other: Heat to ankle

  • Experimental
    Calf heated

    Hot water up to top of calves

    Other: Heat to calf

Interventions

  • OtherHeat to ankle

    Heat administered via hot water to ankle level

  • OtherHeat to calf

    Heat administered via hot water to calf level

06

What researchers measure

Primary outcomes

  1. Blood Glucose

    Time frame: 30 minute

  2. Blood Glucose

    Time frame: 60 minute

  3. Blood Glucose

    Time frame: 90 minute

  4. Blood Glucose

    Time frame: 120 minute

Secondary outcomes

  1. Blood Pressure

    Time frame: 30 min

  2. Blood Pressure

    Time frame: 60 min

  3. Blood Pressure

    Time frame: 90 min

  4. Blood Pressure

    Time frame: 120 min

  5. Tympanic Temperature

    Time frame: 30 min

  6. Tympanic Temperature

    Time frame: 60 min

  7. Tympanic Temperature

    Time frame: 90 min

  8. Tympanic Temperature

    Time frame: 120 min

07

Study locations

1 site
  • San Diego State University
    San Diego, California 92115, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04232098
Lead sponsor
San Diego State University
Responsible party
Jeff Moore (Primary Investigator, San Diego State University) — Principal investigator
First posted
Jan 18, 2020
Start date
Feb 1, 2019
Primary completion
Feb 1, 2021
Completion
Feb 1, 2021
Last update
Mar 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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