Targeting the Carotid Bodies to Reduce Disease Risk Along... | NCT05219994

Studies
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum

NCT05219994

Sponsor

University of Missouri-Columbia

Status

Completed

Last Update Posted

Jul 27, 2023Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Hyperoxia Exposure
Normoxia Exposure

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2020Actual

Primary Completion Date

May 10, 2023Actual

Completion Date

May 10, 2023Actual

First Submitted Date

Jan 21, 2022

First Submission Date that Met QC Criteria

Jan 21, 2022

First Posted Date

Feb 2, 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

Jul 26, 2023

Last Update Posted Date

Jul 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jacqueline K Limberg, PhD, Assistant Professor, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

Our overall goal is to advance our understanding of the contribution of the carotid body chemoreceptors in glucose regulation and the development of type 2 diabetes.

Detailed Description

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Glucose Tolerance Test	Experimental	Subjects will consume a 75 g glucose drink within 1-min and monitored for 2 hours.	Other: Hyperoxia Exposure Other: Normoxia Exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperoxia Exposure	Other	2 hours of hyperoxia exposure during OGTT	Oral Glucose Tolerance Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose change in response to OGTT		2 hours post glucose ingestion
Insulin change in response to OGTT		2 hours post glucose ingestion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy,
type 2 diabetes
BMI 18-40 kg/m2,
non-pregnant,
non-breastfeeding,
non-nicotine users.

Exclusion Criteria:

cardiovascular disease including myocardial infarction, heart failure, coronary artery disease, stroke;
renal or hepatic diseases;
active cancer;
autoimmune diseases;
immunosuppressant therapy;
excessive alcohol consumption (>14 drinks/week);
current nicotine use;
foot ulcers;
diabetic neuropathy;
medication directly influencing sympathetic nervous system activity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacqueline Limberg, Ph.D.	University of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri		Columbia	Missouri	65211	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39197114	Derived	Limberg JK, Ott EP, Pipkins AM, Lis EC, Gonsalves AM, Harper JL, Manrique-Acevedo C. Role of the peripheral chemoreceptors in cardiovascular and metabolic control in type 2 diabetes. J Physiol. 2024 Oct;602(19):4849-4864. doi: 10.1113/JP286975. Epub 2024 Aug 28.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases