Insulin ResistanceEarly Phase 1NCT05518422
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
A Early Phase 1 study testing Hyperinsulinemic, euglycemic infusion in people with Insulin Resistance and Autonomic Dysfunction, run by University of Missouri-Columbia.
Trial summary
The aim of this project is to determine role for ET-1 in individuals with obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Autonomic Dysfunction, Obesity
- What is being tested?
- Hyperinsulinemic, euglycemic infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2024
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age
- Male sex
- Obese (BMI ≥30 kg/m2)
Who cannot join
- Female sex
- Current smoking/Nicotine use
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
- Blood pressure ≥140/90 mmHg
- Diabetes
Show all 9Show fewer
- Vigorous exercise >3 times/week
- Communication barriers
- taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic
About this study
The aim of this project is to determine role for ET-1 in individuals with obesity.
- Conditions
- Insulin Resistance, Autonomic Dysfunction, Obesity
- Being tested
- Hyperinsulinemic, euglycemic infusion
- Medical subject headings
- Insulin Resistance, Primary Dysautonomias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic, euglycemic infusionDrug
60 minute infusion
| Study group | Role | What they receive |
|---|---|---|
| Oral Bosentan | Experimental | Not described Receives: Drug: Hyperinsulinemic, euglycemic infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of muscle sympathetic nerve activity (MSNA)
MSNA burst incidence (bursts/100 heart beats)
Measured: Change from baseline at minute 60
Amount of leg blood flow
Measured with Doppler ultrasound (mL/min)
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 posted26 Aug 2022
- Study startFeb 2024 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- 0 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 K Limberg, Ph.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518422
- Sponsor's protocol ID
- 2090413
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2022
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
- ClinicalTrials.gov ID
- NCT05518422
- Acronym / sponsor ID
- 2090413
- Conditions
- Insulin Resistance, Autonomic Dysfunction, Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 26 Aug 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 aim of this project is to determine role for ET-1 in individuals with obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Bosentan | Experimental | Drug: Hyperinsulinemic, euglycemic infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-55 years of age
- Male sex
- Obese (BMI ≥30 kg/m2)
Key exclusion criteria (9 listed)
- Female sex
- Current smoking/Nicotine use
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
- Blood pressure ≥140/90 mmHg
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 |
|---|---|---|
| Hyperinsulinemic, euglycemic infusion60 minute infusion | Drug | Oral Bosentan |
Primary outcome
Amount of muscle sympathetic nerve activity (MSNA)
Time frame: Change from baseline at minute 60
MSNA burst incidence (bursts/100 heart beats)
Amount of leg blood flow
Time frame: Change from baseline at minute 60
Measured with Doppler ultrasound (mL/min)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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 K Limberg, Ph.D. principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyperinsulinemic, euglycemic infusion in people with Insulin Resistance and Autonomic Dysfunction, run by University of Missouri-Columbia.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 muscle sympathetic nerve activity (MSNA) (time frame: Change from baseline at minute 60). 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?
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 20 Feb 2024.