Role of Endothelin-1 Modulating Insulin-stimulated Blood... | NCT05518422

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

NCT05518422

Sponsor

University of Missouri-Columbia

Status

Withdrawn

Last Update Posted

Feb 20, 2024Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Insulin Resistance
Autonomic Dysfunction
Obesity

Interventions

Hyperinsulinemic, euglycemic infusion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Feb 2024Estimated

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Aug 24, 2022

First Submission Date that Met QC Criteria

Aug 24, 2022

First Posted Date

Aug 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2024

Last Update Posted Date

Feb 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jacqueline K Limberg, PhD, Assistant Professor, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Bosentan	Experimental		Drug: Hyperinsulinemic, euglycemic infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperinsulinemic, euglycemic infusion	Drug	60 minute infusion	Oral Bosentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacqueline K Limberg, Ph.D.	University of Missouri-Columbia	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D054969	Primary Dysautonomias
D009765	Obesity

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided