NCT04232098

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

February 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

January 11, 2020

Last Update Submit

March 18, 2024

Conditions

Postprandial HyperglycemiaHeart Rate Variability

Outcome Measures

Primary Outcomes (4)

  • Blood Glucose

    30 minute

  • Blood Glucose

    60 minute

  • Blood Glucose

    90 minute

  • Blood Glucose

    120 minute

Secondary Outcomes (8)

  • Blood Pressure

    30 min

  • Blood Pressure

    60 min

  • Blood Pressure

    90 min

  • Blood Pressure

    120 min

  • Tympanic Temperature

    30 min

  • +3 more secondary outcomes

Study Arms (3)

Thermoneutral

NO INTERVENTION

thermoneutral condition

Feet heated

EXPERIMENTAL

Hot water up to ankles

Other: Heat to ankle

Calf heated

EXPERIMENTAL

Hot water up to top of calves

Other: Heat to calf

Interventions

Heat to ankleOTHER

Heat administered via hot water to ankle level

Feet heated
Heat to calfOTHER

Heat administered via hot water to calf level

Calf heated

Eligibility Criteria

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

You may qualify if:

  • Anyone within specified age range

You may not qualify if:

  • Anyone outside specified age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92115, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 18, 2020

Study Start

February 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)