NCT05300256

Brief Summary

Effect of peripheral heating on glucose tolerance

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

March 18, 2022

Last Update Submit

April 29, 2024

Conditions

Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Glucose concentrations

    1 hour

Secondary Outcomes (2)

  • Insulin concentrations

    1 hour

  • Blood flow

    1 hour

Study Arms (2)

Peripheral Heating

EXPERIMENTAL

Peripheral Heating

Device: Peripheral Heating

Sham

SHAM COMPARATOR

Sham

Device: Sham

Interventions

Peripheral HeatingDEVICE

Peripheral heating of the feet

Peripheral Heating
ShamDEVICE

Sham

Sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years

You may not qualify if:

  • Open wounds on feet or legs
  • Peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

Central Study Contacts

Jeff Moore

CONTACT

7146587215Jmoore714@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 29, 2022

Study Start

March 18, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

US(1)