Obesity (BMI>30)Early Phase 1NCT07874945
Peripheral Vascular Effects of Insulin in Obesity
A Early Phase 1 study testing human insulin in people with Obesity (BMI>30) and Insulin Resistance, run by University of Missouri-Columbia.
Trial summary
Successful completion of this project will advance our understanding of the role sympathetic nervous system overactivity plays in driving skeletal muscle malperfusion during hyperinsulinemia and consequently impaired glucose uptake in obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (BMI>30), Insulin Resistance
- What is being tested?
- human insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to Jun 2032
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- 18 to 65 years of age
- Individuals with obesity and comorbid IR
- BMI 30-45 kg/m2
- Waist circumference ≥102 cm (men) or ≥88 cm (women)
- HOMA-IR ≥2.5
- Healthy normal weight adults
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- BMI 18-25 kg/m2
- Waist circumference <94 cm (men) and <80 cm (women)
- HOMA-IR <2
Who cannot join
- Pregnancy, breastfeeding
- Unable to provide consent
- Diabetes or polycystic ovarian syndrome
- Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease, stroke
- Nerve/neurologic disease
- Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg)
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- Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
- Current smoking, tobacco, nicotine use
- Use of pharmacological therapy for weight loss
- Body weight change >10% within the last 6 months
- Sensitivity to lidocaine
- Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
- History of hypersensitivity to nitrates
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Successful completion of this project will advance our understanding of the role sympathetic nervous system overactivity plays in driving skeletal muscle malperfusion during hyperinsulinemia and consequently impaired glucose uptake in obesity.
- Conditions
- Obesity (BMI>30), Insulin Resistance
- Being tested
- human insulin
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human insulinDrug
Participants will be administered intra-arterial insulin
| Study group | Role | What they receive |
|---|---|---|
| Healthy normal weight adults | Experimental | Healthy normal weight adults Receives: Drug: human insulin |
| Individuals with obesity and comorbid IR | Experimental | Individuals with obesity and comorbid insulin resistance Receives: Drug: human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow
Measured: 5-minute resting average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874945
- Sponsor's protocol ID
- 2136294
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Vascular Effects of Insulin in Obesity
- ClinicalTrials.gov ID
- NCT07874945
- Acronym / sponsor ID
- 2136294
- Conditions
- Obesity (BMI>30), Insulin Resistance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 15 Oct 2026 (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.
Successful completion of this project will advance our understanding of the role sympathetic nervous system overactivity plays in driving skeletal muscle malperfusion during hyperinsulinemia and consequently impaired glucose uptake in obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy normal weight adults | Experimental | Drug: human insulinHealthy normal weight adults |
| Individuals with obesity and comorbid IR | Experimental | Drug: human insulinIndividuals with obesity and comorbid insulin resistance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 65 years of age
- Individuals with obesity and comorbid IR
- BMI 30-45 kg/m2
- Waist circumference ≥102 cm (men) or ≥88 cm (women)
- HOMA-IR ≥2.5
Key exclusion criteria (13 listed)
- Pregnancy, breastfeeding
- Unable to provide consent
- Diabetes or polycystic ovarian syndrome
- Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease, stroke
- Nerve/neurologic disease
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 |
|---|---|---|
| human insulinParticipants will be administered intra-arterial insulin | Drug | Healthy normal weight adults, Individuals with obesity and comorbid IR |
Primary outcome
Forearm blood flow
Time frame: 5-minute resting average
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing human insulin in people with Obesity (BMI>30) and Insulin Resistance, 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 9 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Limberg (573-882-2544, limberglab@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm blood flow (time frame: 5-minute resting average). 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 15 Oct 2026.