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

Early Phase 1

Withdrawn

• Conditions: Insulin Resistance; Autonomic Dysfunction; Obesity
• Interventions: Drug: Hyperinsulinemic, euglycemic infusion

• Registration Number: NCT05518422
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Status Verified: 2024-02
• Study Start: 2024-02
• Primary Completion: 2024-02
• Study Completion: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• 18-55 years of age
• Male sex
• 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
• Diabetes
• Vigorous exercise >3 times/week
• Communication barriers
• taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Bosentan	Hyperinsulinemic, euglycemic infusion	-

Primary Outcome Measures

Name	Time	Method
Amount of muscle sympathetic nerve activity (MSNA)	Change from baseline at minute 60	MSNA burst incidence (bursts/100 heart beats)
Amount of leg blood flow	Change from baseline at minute 60	Measured with Doppler ultrasound (mL/min)