NCT05244694

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 7, 2022

Last Update Submit

February 16, 2023

Conditions

VasoconstrictionHealthyInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Amount of leg blood flow

    Measured with Doppler ultrasound (mL/min)

    Change from baseline at minute 60

Secondary Outcomes (2)

  • Amount of muscle sympathetic nerve activity (MSNA)

    Change from baseline at minute 60

  • Amount of cerebral blood flow

    Change from baseline at minute 60

Study Arms (1)

Insulin

EXPERIMENTAL

Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion.

Drug: Insulin

Interventions

InsulinDRUG

Priming dose then a constant infusion at 40 mU•m-2•min-1

Insulin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adult men and women;
  • years of age;
  • BMI 18-30 kg/m2;
  • non-pregnant/non-breastfeeding;
  • non-nicotine users;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jacqueline L Limberg, Ph.D.

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 17, 2022

Study Start

August 6, 2020

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

US(1)