Obesity (BMI>30)Early Phase 1NCT07653464
Interplay of Central and 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 at 1 site in United States.
Trial summary
Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation. 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
- 1 siteUnited States
- Study dates
- 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
- Adherence to >150 min/week of moderate-to-vigorous physical activity/exercise
- Participation in any other research study or medical procedure involving significant ionizing radiation exposure in the past 12 months
- Claustrophobia
- Non-MRI compatible metal implants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Missouri
Columbia, Missouri, 65211
Jacqueline Limberg, 573-882-2544, limberglab@missouri.edu
Jacqueline Limberg
About this study
Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.
- 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 human insulin (160 IU) using an intra-nasal device.
| Study group | Role | What they receive |
|---|---|---|
| Insulin (Doppler) | Experimental | Human insulin (160 IU) will be administered using an intra-nasal device Receives: Drug: human insulin |
| Insulin (MRI) | Experimental | Human insulin (160 IU) will be administered using an intra-nasal device. Receives: Drug: human insulin |
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 30
Amount of cerebral blood flow
Measured with arterial spin labeling (mL/100 g/min)
Measured: Change from baseline at minute 30
Amount of leg blood flow
Measured with Doppler ultrasound (mL/min)
Measured: Change from baseline at minute 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startDec 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
- NCT07653464
- Sponsor's protocol ID
- 2134707
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 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