Back to resultsImpact 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
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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
NCT ID
NCT05153395
First Posted
November 18, 2021
Last Updated
July 26, 2023
Sponsor
University of Missouri-Columbia
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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