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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05244694
Other study ID # 2020286
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date August 6, 2020
Est. completion date June 25, 2021

Study information

Verified date February 2023
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 25, 2021
Est. primary completion date June 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of leg blood flow Measured with Doppler ultrasound (mL/min) Change from baseline at minute 60
Secondary Amount of muscle sympathetic nerve activity (MSNA) MSNA burst incidence (bursts/100 heart beats) Change from baseline at minute 60
Secondary Amount of cerebral blood flow Measured with trans-cranial Doppler ultrasound (cm/s) Change from baseline at minute 60
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