NCT05518422WithdrawnEarly Phase 1
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
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- Withdrawn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
Jacqueline K Limberg, PhD
Assistant Professor
University of Missouri-Columbia
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