Peripheral Heating and Glucose Tolerance | NCT05300256

Studies
Peripheral Heating and Glucose Tolerance

NCT05300256

Sponsor

San Diego State University

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Glucose Tolerance

Interventions

Peripheral Heating
Sham

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2022Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Mar 18, 2022

First Submission Date that Met QC Criteria

Mar 18, 2022

First Posted Date

Mar 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2024

Last Update Posted Date

Apr 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peripheral Heating	Experimental	Peripheral Heating	Device: Peripheral Heating
Sham	Sham Comparator	Sham	Device: Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peripheral Heating	Device	Peripheral heating of the feet	Peripheral Heating

Measure	Description	Time Frame
Glucose concentrations		1 hour

Measure	Description	Time Frame
Insulin concentrations		1 hour
Blood flow		1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-80 years

Exclusion Criteria:

Open wounds on feet or legs
Peripheral neuropathy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeff Moore	Contact	7146587215		Jmoore714@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Diego State University	Recruiting	San Diego	California	92182	United States