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Autonomic Nervous System and Nitric Oxide Interactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01137253
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Drug: Trimethaphan Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: The Autonomic Nervous System, Nitric Oxide and TPA Interactions
Study Start Date : June 2010
Primary Completion Date : January 2017
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Trimethaphan
Response to intrabrachial vasodilators during autonomic withdrawal
Drug: Trimethaphan
Trimethaphan 4 mg/min IV, for the duration of the study (approximately 2 hours)
Other Name: Blocked
Placebo Comparator: Placebo
Response to intrabrachial vasodilators during saline intravenous (IV) infusion
Drug: Placebo
Response to intrabrachial vasodilators during IV saline infusion
Other Name: Intact


Outcome Measures

Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: 2 hours ]
    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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For lean healthy volunteers:

  • 20 subjects (10 males and 10 females) aged 18-60 yr.
  • All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
  • Body mass index < 25Kg/m2 .
  • Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.

For Obese subjects with high blood pressure.

  • 20 subjects (10 males and 10 females) aged 18-60 yr.
  • All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
  • Body mass index > 30 and less than 40 Kg/m2

    *High blood pressure (systolic=130 and diastolic = 85 mmHg)

  • Female volunteers of childbearing potential will undergo serum HCG pregnancy test at screening and urine HCG pregnancy test again on the study day.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137253


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
More Information

Responsible Party: Alfredo Gamboa, Research Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01137253     History of Changes
Other Study ID Numbers: 091489
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Alfredo Gamboa, Vanderbilt University:
Nitric Oxide
Autonomic Nervous System

Additional relevant MeSH terms:
Nitric Oxide
Trimethaphan
Trimethaphan camsylate
Vasodilator Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Gasotransmitters
Protective Agents
Adjuvants, Anesthesia
Antihypertensive Agents
Ganglionic Blockers
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents