Clinical trial

Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

Name

2020286

Description

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

Trial arms

Trial start

2020-08-06

Estimated PCD

2021-06-25

Trial end

2021-06-25

Status

Completed

Phase

Early phase I

Treatment

Insulin

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

Arms:

Insulin

Size

Primary endpoint

Amount of leg blood flow

Change from baseline at minute 60

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-02-17

1 organization

1 product

3 indications

Organization

University of Missouri-Columbia

Product

Indication

Indication

Indication