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

NCT05518422 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 2090413
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insulin Resistance; Autonomic Dysfunction; Obesity

Outcome Measures

Primary Outcomes (2)

• Amount of muscle sympathetic nerve activity (MSNA)

  MSNA burst incidence (bursts/100 heart beats)

  Change from baseline at minute 60

• Amount of leg blood flow

  Measured with Doppler ultrasound (mL/min)

  Change from baseline at minute 60

Study Arms (1)

Oral Bosentan

EXPERIMENTAL

Drug: Hyperinsulinemic, euglycemic infusion

Interventions

Hyperinsulinemic, euglycemic infusion DRUG

60 minute infusion

Oral Bosentan

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Male sex
• Obese (BMI ≥30 kg/m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Conditions

Insulin Resistance; Primary Dysautonomias; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autonomic Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacqueline K Limberg, Ph.D.

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: February 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02