search
Back to results

Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

Primary Purpose

Vasoconstriction, Healthy, Insulin Resistance

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
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 Vasoconstriction

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 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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin

Arm Description

Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion.

Outcomes

Primary Outcome Measures

Amount of leg blood flow
Measured with Doppler ultrasound (mL/min)

Secondary Outcome Measures

Amount of muscle sympathetic nerve activity (MSNA)
MSNA burst incidence (bursts/100 heart beats)
Amount of cerebral blood flow
Measured with trans-cranial Doppler ultrasound (cm/s)

Full Information

First Posted
February 7, 2022
Last Updated
February 16, 2023
Sponsor
University of Missouri-Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT05244694
Brief Title
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Official Title
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

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
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin
Arm Type
Experimental
Arm Description
Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Priming dose then a constant infusion at 40 mU•m-2•min-1
Primary Outcome Measure Information:
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 muscle sympathetic nerve activity (MSNA)
Description
MSNA burst incidence (bursts/100 heart beats)
Time Frame
Change from baseline at minute 60
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 18-30 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline L 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

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

We'll reach out to this number within 24 hrs