NCT05219994

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable type-2-diabetes

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

September 9, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

January 21, 2022

Last Update Submit

July 26, 2023

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Glucose change in response to OGTT

    2 hours post glucose ingestion

  • Insulin change in response to OGTT

    2 hours post glucose ingestion

Study Arms (1)

Oral Glucose Tolerance Test

EXPERIMENTAL

Subjects will consume a 75 g glucose drink within 1-min and monitored for 2 hours.

Other: Hyperoxia ExposureOther: Normoxia Exposure

Interventions

Hyperoxia ExposureOTHER

2 hours of hyperoxia exposure during OGTT

Oral Glucose Tolerance Test
Normoxia ExposureOTHER

2 hours of normoxia exposure during OGTT

Oral Glucose Tolerance Test

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jacqueline Limberg, Ph.D.

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: After screening, participants will complete two study visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 2, 2022

Study Start

September 9, 2020

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)