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Clinical Trials/NCT05518422
NCT05518422WithdrawnEarly Phase 1

Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity

University of Missouri-Columbia0 sitesStarted: February 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Withdrawn
Primary Endpoint
Amount of muscle sympathetic nerve activity (MSNA)

Study Overview

Brief Summary

The aim of this project is to determine role for ET-1 in individuals with obesity.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 18-55 years of age
  • Obese (BMI ≥30 kg/m2)

Exclusion Criteria

  • Female sex
  • Current smoking/Nicotine use
  • Nerve/neurologic disease
  • Cardiovascular, hepatic, renal, respiratory disease
  • Blood pressure ≥140/90 mmHg
  • Vigorous exercise >3 times/week
  • Communication barriers
  • taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Arms & Interventions

Oral Bosentan

Experimental

Intervention: Hyperinsulinemic, euglycemic infusion (Drug)

Outcomes

Primary Outcomes

Amount of muscle sympathetic nerve activity (MSNA)

Time Frame: Change from baseline at minute 60

MSNA burst incidence (bursts/100 heart beats)

Amount of leg blood flow

Time Frame: Change from baseline at minute 60

Measured with Doppler ultrasound (mL/min)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacqueline K Limberg, PhD

Assistant Professor

University of Missouri-Columbia

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