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Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

Primary Purpose

Healthy, Vasodilation, Insulin Resistance

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carbon dioxide breathing
Neurovascular Coupling
Human insulin
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin

Arm Description

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

Outcomes

Primary Outcome Measures

Amount of muscle sympathetic nerve activity (MSNA)
MSNA burst incidence (bursts/100 heart beats)
Amount of leg blood flow
Measured with Doppler ultrasound (mL/min)

Secondary Outcome Measures

Amount of cerebral blood flow
Measured with trans-cranial Doppler ultrasound (cm/s)

Full Information

First Posted
November 18, 2021
Last Updated
July 26, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05153395
Brief Title
Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation
Official Title
Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Vasodilation, Insulin Resistance, Autonomic Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin
Arm Type
Experimental
Arm Description
Human insulin (160 IU) will be administered as a bolus using an intra-nasal device.
Intervention Type
Other
Intervention Name(s)
Carbon dioxide breathing
Intervention Description
Hypercapnic (5% carbon dioxide) air will be administered before and after intra-nasal insulin exposure.
Intervention Type
Other
Intervention Name(s)
Neurovascular Coupling
Intervention Description
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
Drug
Intervention Name(s)
Human insulin
Intervention Description
Participants will be administered human insulin (160 IU) as a bolus using an intra-nasal device.
Primary Outcome Measure Information:
Title
Amount of muscle sympathetic nerve activity (MSNA)
Description
MSNA burst incidence (bursts/100 heart beats)
Time Frame
Change from baseline at minute 60
Title
Amount of leg blood flow
Description
Measured with Doppler ultrasound (mL/min)
Time Frame
Change from baseline at minute 60
Secondary Outcome Measure Information:
Title
Amount of cerebral blood flow
Description
Measured with trans-cranial Doppler ultrasound (cm/s)
Time Frame
Change from baseline at minute 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Harper, B.S.
Phone
5738822544
Email
harperjl@missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline K Limberg, Ph.D.
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Harper
Phone
573-882-2544
Email
harperjl@missouri.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

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