NCT01137253

Brief Summary

The investigators are interested in the role of the autonomic nervous system in the regulation of endothelial function among obese hypertensive subjects. In particular, the investigators will study how endothelial function (response to intra-arterial acetylcholine) changes during autonomic withdrawal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

6.6 years

First QC Date

June 1, 2010

Last Update Submit

February 27, 2018

Conditions

Endothelial Dysfunction

Keywords

Nitric OxideAutonomic Nervous System

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    The dose response curve to intrabrachial vasodilators will be determined using the peak forearm blood flow during the last 5 minutes of each drug infusion

    2 hours

Study Arms (2)

Trimethaphan

EXPERIMENTAL

Response to intrabrachial vasodilators during autonomic withdrawal

Drug: Trimethaphan

Placebo

PLACEBO COMPARATOR

Response to intrabrachial vasodilators during saline intravenous (IV) infusion

Drug: Placebo

Interventions

TrimethaphanDRUG

Trimethaphan 4 mg/min IV, for the duration of the study (approximately 2 hours)

Also known as: Blocked
Trimethaphan
PlaceboDRUG

Response to intrabrachial vasodilators during IV saline infusion

Also known as: Intact
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Pregnant females
  • Subjects unable to give voluntary informed consent
  • Subjects on anticoagulant drugs or anemic
  • Subjects with a recent medical illness
  • Subjects with a history of coronary heart disease
  • Subjects with known kidney or liver disease
  • Subjects with recent weight loss or consuming low carbohydrate diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

TrimethaphanDental Occlusion

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 4, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

US(1)