Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity

NCT07653464 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2134707
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study, we seek to determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.

Conditions

Obesity (BMI>30); Insulin Resistance

Outcome Measures

Primary Outcomes (3)

• Amount of muscle sympathetic nerve activity (MSNA)

  MSNA burst incidence (bursts/100 heart beats)

  Change from baseline at minute 30

• Amount of cerebral blood flow

  Measured with arterial spin labeling (mL/100 g/min)

  Change from baseline at minute 30

• Amount of leg blood flow

  Measured with Doppler ultrasound (mL/min)

  Change from baseline at minute 30

Study Arms (2)

Insulin (Doppler)

EXPERIMENTAL

Human insulin (160 IU) will be administered using an intra-nasal device

Drug: human insulin

Insulin (MRI)

EXPERIMENTAL

Human insulin (160 IU) will be administered using an intra-nasal device.

Drug: human insulin

Interventions

human insulin DRUG

Participants will be administered human insulin (160 IU) using an intra-nasal device.

Insulin (Doppler); Insulin (MRI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jacqueline Limberg

CONTACT

573-882-2544; limberglab@missouri.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)