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Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

NCT ID: NCT05153395

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

EARLY_PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Vasodilation Insulin Resistance Autonomic Dysfunction Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Insulin (Doppler)

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

Group Type EXPERIMENTAL

Carbon dioxide breathing

Intervention Type OTHER

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

Neurovascular Coupling

Intervention Type OTHER

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 insulin

Intervention Type DRUG

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

Insulin (MRI)

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

Group Type EXPERIMENTAL

Carbon dioxide breathing

Intervention Type OTHER

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

Human insulin

Intervention Type DRUG

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

Time Control (Doppler)

Time control only

Group Type OTHER

Carbon dioxide breathing

Intervention Type OTHER

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

Neurovascular Coupling

Intervention Type OTHER

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.

Interventions

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Carbon dioxide breathing

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

Intervention Type OTHER

Neurovascular Coupling

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.

Intervention Type OTHER

Human insulin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jacqueline K Limberg, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacqueline K Limberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2057288

Identifier Type: -

Identifier Source: org_study_id