Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

February 16, 2023 updated by: Jacqueline K Limberg, PhD, University of Missouri-Columbia
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of leg blood flow
Time Frame: Change from baseline at minute 60
Measured with Doppler ultrasound (mL/min)
Change from baseline at minute 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of muscle sympathetic nerve activity (MSNA)
Time Frame: Change from baseline at minute 60
MSNA burst incidence (bursts/100 heart beats)
Change from baseline at minute 60
Amount of cerebral blood flow
Time Frame: Change from baseline at minute 60
Measured with trans-cranial Doppler ultrasound (cm/s)
Change from baseline at minute 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Actual)

June 25, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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