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
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.
- 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