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Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

Sponsor
University of Missouri-Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05153395
Collaborator
(none)
27
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Carbon dioxide breathing
  • Other: Neurovascular Coupling
  • Drug: Human insulin
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Insulin

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

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

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.

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

Outcome Measures

Primary Outcome Measures

  1. Amount of muscle sympathetic nerve activity (MSNA) [Change from baseline at minute 60]

    MSNA burst incidence (bursts/100 heart beats)

  2. Amount of leg blood flow [Change from baseline at minute 60]

    Measured with Doppler ultrasound (mL/min)

Secondary Outcome Measures

  1. Amount of cerebral blood flow [Change from baseline at minute 60]

    Measured with trans-cranial Doppler ultrasound (cm/s)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • healthy adult men and women;

  • 18-45 years of age;

  • BMI 18-30 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Missouri Columbia Missouri United States 65211

Sponsors and Collaborators

  • University of Missouri-Columbia

Investigators

  • Principal Investigator: Jacqueline K Limberg, Ph.D., University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacqueline K Limberg, PhD, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT05153395
Other Study ID Numbers:
  • 2057288
First Posted:
Dec 10, 2021
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Insulin Resistance
Insulin
Insulin, Globin Zinc

Study Results

No Results Posted as of Feb 4, 2022