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Effect of Feet and Calf Heating on Glucose Tolerance and Heart Rate Variability

Primary Purpose

Postprandial Hyperglycemia, Heart Rate Variability

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heat to ankle
Heat to calf
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postprandial Hyperglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Anyone within specified age range

Exclusion Criteria:

  • Anyone outside specified age range

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Thermoneutral

    Feet heated

    Calf heated

    Arm Description

    thermoneutral condition

    Hot water up to ankles

    Hot water up to top of calves

    Outcomes

    Primary Outcome Measures

    Blood Glucose
    Blood Glucose
    Blood Glucose
    Blood Glucose
    Heart Rate Variability
    Heart Rate Variability
    Heart Rate Variability
    Heart Rate Variability

    Secondary Outcome Measures

    Blood Pressure
    Blood Pressure
    Blood Pressure
    Blood Pressure
    Tympanic Temperature
    Tympanic Temperature
    Tympanic Temperature
    Tympanic Temperature

    Full Information

    First Posted
    January 11, 2020
    Last Updated
    January 14, 2020
    Sponsor
    San Diego State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04232098
    Brief Title
    Effect of Feet and Calf Heating on Glucose Tolerance and Heart Rate Variability
    Official Title
    Effect of Feet and Calf Heating on Glucose Tolerance and Heart Rate Variability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Diego State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Determine the effect of feet and calf heating on glucose tolerance and heart rate variability relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postprandial Hyperglycemia, Heart Rate Variability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thermoneutral
    Arm Type
    No Intervention
    Arm Description
    thermoneutral condition
    Arm Title
    Feet heated
    Arm Type
    Experimental
    Arm Description
    Hot water up to ankles
    Arm Title
    Calf heated
    Arm Type
    Experimental
    Arm Description
    Hot water up to top of calves
    Intervention Type
    Other
    Intervention Name(s)
    Heat to ankle
    Intervention Description
    Heat administered via hot water to ankle level
    Intervention Type
    Other
    Intervention Name(s)
    Heat to calf
    Intervention Description
    Heat administered via hot water to calf level
    Primary Outcome Measure Information:
    Title
    Blood Glucose
    Time Frame
    30 minute
    Title
    Blood Glucose
    Time Frame
    60 minute
    Title
    Blood Glucose
    Time Frame
    90 minute
    Title
    Blood Glucose
    Time Frame
    120 minute
    Title
    Heart Rate Variability
    Time Frame
    30 min
    Title
    Heart Rate Variability
    Time Frame
    60 min
    Title
    Heart Rate Variability
    Time Frame
    90 min
    Title
    Heart Rate Variability
    Time Frame
    120 min
    Secondary Outcome Measure Information:
    Title
    Blood Pressure
    Time Frame
    30 min
    Title
    Blood Pressure
    Time Frame
    60 min
    Title
    Blood Pressure
    Time Frame
    90 min
    Title
    Blood Pressure
    Time Frame
    120 min
    Title
    Tympanic Temperature
    Time Frame
    30 min
    Title
    Tympanic Temperature
    Time Frame
    60 min
    Title
    Tympanic Temperature
    Time Frame
    90 min
    Title
    Tympanic Temperature
    Time Frame
    120 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Anyone within specified age range Exclusion Criteria: Anyone outside specified age range

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Feet and Calf Heating on Glucose Tolerance and Heart Rate Variability

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