Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation

Healthy Clinical Trial

Official title:

Novel Treatment for Brain Insulin Resistance and Hypoperfusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153395
• Other study ID #: 2057288
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 1, 2021
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: University of Missouri-Columbia
• Contact: Jacqueline K Limberg, Ph.D.
• Phone: 5738822544
• Email: limbergj[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Healthy
• Insulin Resistance
• Obesity
• Primary Dysautonomias
• Vasodilation

Intervention

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

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of cerebral blood flow	Measured with trans-cranial Doppler ultrasound (cm/s) or arterial spin labeling (mL/100 g/min)	Change from baseline at minute 15
Secondary	Amount of muscle sympathetic nerve activity (MSNA)	MSNA burst incidence (bursts/100 heart beats)	Change from baseline at minute 15
Secondary	Amount of leg blood flow	Measured with Doppler ultrasound (mL/min)	Change from baseline at minute 15