Back to resultsRole of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
Primary Purpose
Insulin Resistance, Autonomic Dysfunction, Obesity
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Hyperinsulinemic, euglycemic infusion
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral Bosentan
Arm Description
Outcomes
Primary Outcome Measures
Amount of muscle sympathetic nerve activity (MSNA)
MSNA burst incidence (bursts/100 heart beats)
Amount of leg blood flow
Measured with Doppler ultrasound (mL/min)
Secondary Outcome Measures
Full Information
NCT ID
NCT05518422
First Posted
August 24, 2022
Last Updated
July 26, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05518422
Brief Title
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
Official Title
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this project is to determine role for ET-1 in individuals with obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Autonomic Dysfunction, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Bosentan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyperinsulinemic, euglycemic infusion
Intervention Description
60 minute infusion
Primary Outcome Measure Information:
Title
Amount of muscle sympathetic nerve activity (MSNA)
Description
MSNA burst incidence (bursts/100 heart beats)
Time Frame
Change from baseline at minute 60
Title
Amount of leg blood flow
Description
Measured with Doppler ultrasound (mL/min)
Time Frame
Change from baseline at minute 60
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Harper, B.S.
Phone
573-882-2544
Email
harperjl@missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline K Limberg, Ph.D.
Phone
573-882-2420
Email
limbergj@Missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline K Limberg, Ph.D.
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity
We'll reach out to this number within 24 hrs