Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05244694
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.

Condition or Disease	Intervention/Treatment	Phase
Vasoconstriction; Healthy; Insulin Resistance	Drug: Insulin	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
• Actual Study Start Date: Aug 6, 2020
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion.	Drug: Insulin; Priming dose then a constant infusion at 40 mU•m-2•min-1

Outcome Measures

Primary Outcome Measures

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

   Measured with Doppler ultrasound (mL/min)

Secondary 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 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 functions

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, excessive alcohol consumption;

• hypertension;

• active cancer;

• autoimmune disease;

• immunosuppressant therapy

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 L 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: NCT05244694
• Other Study ID Numbers: 2020286
• First Posted: Feb 17, 2022
• Last Update Posted: Feb 17, 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
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Insulin Resistance; Insulin

Study Results

No Results Posted as of Feb 17, 2022