Autonomic Nervous System and Nitric Oxide Interactions

NCT ID: NCT01137253

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Trimethaphan

Response to intrabrachial vasodilators during autonomic withdrawal

Group Type EXPERIMENTAL

Trimethaphan

Intervention Type DRUG

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

Placebo

Response to intrabrachial vasodilators during saline intravenous (IV) infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Response to intrabrachial vasodilators during IV saline infusion

Interventions

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Trimethaphan

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

Intervention Type DRUG

Placebo

Response to intrabrachial vasodilators during IV saline infusion

Intervention Type DRUG

Other Intervention Names

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Blocked Intact

Eligibility Criteria

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Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Alfredo Gamboa

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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091489

Identifier Type: -

Identifier Source: org_study_id

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