Autonomic Nervous System and Nitric Oxide Interactions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alfredo Gamboa, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01137253
First received: June 1, 2010
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
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 Intervention
Endothelial Dysfunction
Drug: Trimethaphan
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: The Autonomic Nervous System, Nitric Oxide and TPA Interactions

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 21
Study Start Date: June 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 1, 2010
Last Updated: April 26, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Nitric Oxide
Autonomic Nervous System

Additional relevant MeSH terms:
Nitric Oxide
Trimethaphan
Trimethaphan camsylate
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
Vasodilator Agents
Gasotransmitters
Protective Agents
Adjuvants, Anesthesia
Antihypertensive Agents
Ganglionic Blockers
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 21, 2016