- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07653464
Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity
June 12, 2026 updated by: Jacqueline K Limberg, PhD, University of Missouri-Columbia
In the present study, we seek to determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jacqueline Limberg
- Phone Number: 573-882-2544
- Email: limberglab@missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
Contact:
- Jacqueline Limberg
- Phone Number: 573-882-2544
- Email: limberglab@missouri.edu
-
Principal Investigator:
- Jacqueline Limberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
- BMI 18-25 kg/m2
- Waist circumference <94 cm (men) and <80 cm (women)
- HOMA-IR <2
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Insulin (Doppler)
Human insulin (160 IU) will be administered using an intra-nasal device
|
Participants will be administered human insulin (160 IU) using an intra-nasal device.
|
|
Experimental: Insulin (MRI)
Human insulin (160 IU) will be administered using an intra-nasal device.
|
Participants will be administered human insulin (160 IU) using an intra-nasal device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of muscle sympathetic nerve activity (MSNA)
Time Frame: Change from baseline at minute 30
|
MSNA burst incidence (bursts/100 heart beats)
|
Change from baseline at minute 30
|
|
Amount of cerebral blood flow
Time Frame: Change from baseline at minute 30
|
Measured with arterial spin labeling (mL/100 g/min)
|
Change from baseline at minute 30
|
|
Amount of leg blood flow
Time Frame: Change from baseline at minute 30
|
Measured with Doppler ultrasound (mL/min)
|
Change from baseline at minute 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2032
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Hyperinsulinism
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Insulin Resistance
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Peptide Hormones
- Peptides
- Amino Acids, Peptides, and Proteins
- Insulins
- Pancreatic Hormones
- Proinsulin
- Insulin
Other Study ID Numbers
- 2134707
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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