Type 2 DiabetesNCT05219994
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
A study testing Hyperoxia Exposure and Normoxia Exposure in people with Type 2 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Hyperoxia Exposure and Normoxia Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy,
- type 2 diabetes
- BMI 18-40 kg/m2,
- non-pregnant,
- non-breastfeeding,
- non-nicotine users.
Who cannot join
- 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);
Show all 10Show fewer
- current nicotine use;
- foot ulcers;
- diabetic neuropathy;
- medication directly influencing sympathetic nervous system activity
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Hyperoxia Exposure, Normoxia Exposure
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperoxia ExposureOther
2 hours of hyperoxia exposure during OGTT
Normoxia ExposureOther
2 hours of normoxia exposure during OGTT
| Study group | Role | What they receive |
|---|---|---|
| Oral Glucose Tolerance Test | Experimental | Subjects will consume a 75 g glucose drink within 1-min and monitored for 2 hours. Receives: Other: Hyperoxia Exposure; Other: Normoxia Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose change in response to OGTT
Measured: 2 hours post glucose ingestion
Insulin change in response to OGTT
Measured: 2 hours post glucose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start9 Sep 2020
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After screening, participants will complete two study visits.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline K Limberg, PhD, University of Missouri-Columbia
- Investigators
- Jacqueline Limberg, Ph.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219994
- Sponsor's protocol ID
- 2018486
- Status last verified
- Jul 2023
- First submitted
- 21 Jan 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39197114
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
- ClinicalTrials.gov ID
- NCT05219994
- Acronym / sponsor ID
- 2018486
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After screening, participants will complete two study visits.
| Arm | Type | Receives |
|---|---|---|
| Oral Glucose Tolerance Test | Experimental | Other: Hyperoxia Exposure, Other: Normoxia ExposureSubjects will consume a 75 g glucose drink within 1-min and monitored for 2 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy,
- type 2 diabetes
- BMI 18-40 kg/m2,
- non-pregnant,
- non-breastfeeding,
Key exclusion criteria (10 listed)
- cardiovascular disease including myocardial infarction, heart failure, coronary artery disease, stroke;
- renal or hepatic diseases;
- active cancer;
- autoimmune diseases;
- immunosuppressant therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperoxia Exposure2 hours of hyperoxia exposure during OGTT | Other | Oral Glucose Tolerance Test |
| Normoxia Exposure2 hours of normoxia exposure during OGTT | Other | Oral Glucose Tolerance Test |
Primary outcome
Glucose change in response to OGTT
Time frame: 2 hours post glucose ingestion
Insulin change in response to OGTT
Time frame: 2 hours post glucose ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 39197114Limberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Limberg, Ph.D. principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperoxia Exposure and Normoxia Exposure in people with Type 2 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose change in response to OGTT (time frame: 2 hours post glucose ingestion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.