VasoconstrictionEarly Phase 1NCT05244694
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
A Early Phase 1 study testing Insulin in people with Vasoconstriction and Healthy, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasoconstriction, Healthy, Insulin Resistance
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 25 Jun 2021
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult men and women;
- 18-45 years of age;
- BMI 18-30 kg/m2;
- non-pregnant/non-breastfeeding;
- non-nicotine users;
Who cannot join
- taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions
- Self-reported history of:
- hepatic, renal, pulmonary, cardiovascular, or neurological disease;
- stroke or neurovascular disease;
- bleeding/clotting disorders;
- sleep apnea or other sleep disorders;
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- diabetes;
- smoking;
- history of alcoholism or substance abuse, excessive alcohol consumption;
- hypertension;
- active cancer;
- autoimmune disease;
- immunosuppressant therapy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.
- Conditions
- Vasoconstriction, Healthy, Insulin Resistance
- Being tested
- Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Priming dose then a constant infusion at 40 mU•m-2•min-1
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of leg blood flow
Measured with Doppler ultrasound (mL/min)
Measured: Change from baseline at minute 60
Secondary outcomes (2)
Amount of muscle sympathetic nerve activity (MSNA)
MSNA burst incidence (bursts/100 heart beats)
Measured: Change from baseline at minute 60
Amount of cerebral blood flow
Measured with trans-cranial Doppler ultrasound (cm/s)
Measured: Change from baseline at minute 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start6 Aug 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasoconstrictionStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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 L Limberg, Ph.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244694
- Sponsor's protocol ID
- 2020286
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
- ClinicalTrials.gov ID
- NCT05244694
- Acronym / sponsor ID
- 2020286
- Conditions
- Vasoconstriction, Healthy, Insulin Resistance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 17 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.
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Drug: InsulinParticipants will complete a 60 minute hyperinsulinemic-euglycemic infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy adult men and women;
- 18-45 years of age;
- BMI 18-30 kg/m2;
- non-pregnant/non-breastfeeding;
- non-nicotine users;
Key exclusion criteria (13 listed)
- taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions
- hepatic, renal, pulmonary, cardiovascular, or neurological disease;
- stroke or neurovascular disease;
- bleeding/clotting disorders;
- sleep apnea or other sleep disorders;
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 |
|---|---|---|
| InsulinPriming dose then a constant infusion at 40 mU•m-2•min-1 | Drug | Insulin |
Primary outcome
Amount of leg blood flow
Time frame: Change from baseline at minute 60
Measured with Doppler ultrasound (mL/min)
2 secondary outcomes
Amount of muscle sympathetic nerve activity (MSNA)
Time frame: Change from baseline at minute 60
Amount of cerebral blood flow
Time frame: Change from baseline at minute 60
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 17 Feb 2023.
- 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 L 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 Early Phase 1 study testing Insulin in people with Vasoconstriction and Healthy, 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 5 inclusion and 13 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 17 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of leg blood flow (time frame: Change from baseline at minute 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.