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OpenTrials
Completed

NCT Number: NCT05244694

Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

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

Completed

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Key information

Conditions

Vasoconstriction Glucose Metabolism Disorders Healthy Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

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

Primary outcomes

  1. Amount of leg blood flow

    Time frame: Change from baseline at minute 60

    Measured with Doppler ultrasound (mL/min)

Secondary outcomes

  1. Amount of muscle sympathetic nerve activity (MSNA)

    Time frame: Change from baseline at minute 60

    MSNA burst incidence (bursts/100 heart beats)

  2. Amount of cerebral blood flow

    Time frame: Change from baseline at minute 60

    Measured with trans-cranial Doppler ultrasound (cm/s)

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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