Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

Early Phase 1SuspendedNCT05153395

University of Missouri-Columbia65 enrolled

Overview

The purpose of this project is to examine the impact of increases in brain insulin on sympathetic nervous system activity, as well as peripheral and cerebral blood flow in humans.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Vasodilation Insulin Resistance Autonomic Dysfunction Obesity

Interventions

Carbon dioxide breathingOTHER

Hypercapnic (5% carbon dioxide) air will be administered before and after intra-nasal insulin exposure.

Neurovascular CouplingOTHER

Participants will be asked to repeatedly open and close their eyes. With eyes open, participants will focus on a visual image. This will be done before and after intra-nasal insulin exposure.

Human insulinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy adult men and women; * 18-45 years of age; * BMI \>18 kg/m2; * non-pregnant/non-breastfeeding; * non-nicotine users; Exclusion Criteria: * taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic Self-reported history of: * hepatic, renal, pulmonary, cardiovascular, or neurological disease; * stroke or neurovascular disease; * bleeding/clotting disorders; * sleep apnea or other sleep disorders; * diabetes; * smoking; * history of alcoholism or substance abuse; * hypertension; * respiratory disease; * active cancer; * autoimmune disease.

Locations (1)

University of Missouri

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Amount of cerebral blood flow

Measured with trans-cranial Doppler ultrasound (cm/s) or arterial spin labeling (mL/100 g/min)

Time frame: Change from baseline at minute 15

Secondary Outcomes

Amount of muscle sympathetic nerve activity (MSNA)

MSNA burst incidence (bursts/100 heart beats)

Time frame: Change from baseline at minute 15

Amount of leg blood flow

Measured with Doppler ultrasound (mL/min)

Time frame: Change from baseline at minute 15

Data from ClinicalTrials.gov

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