- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05219994
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
July 26, 2023 updated by: Jacqueline K Limberg, PhD, University of Missouri-Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Glucose Tolerance Test
Subjects will consume a 75 g glucose drink within 1-min and monitored for 2 hours.
|
2 hours of hyperoxia exposure during OGTT
2 hours of normoxia exposure during OGTT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose change in response to OGTT
Time Frame: 2 hours post glucose ingestion
|
2 hours post glucose ingestion
|
Insulin change in response to OGTT
Time Frame: 2 hours post glucose ingestion
|
2 hours post glucose ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacqueline Limberg, Ph.D., University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2020
Primary Completion (Actual)
May 10, 2023
Study Completion (Actual)
May 10, 2023
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
January 21, 2022
First Posted (Actual)
February 2, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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