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OpenTrials
Completed

NCT Number: NCT01137253

Autonomic Nervous System and Nitric Oxide Interactions

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.

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Key information

Conditions

Endothelial Dysfunction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethaphan

Drug

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

Other names: Blocked

Placebo

Drug

Response to intrabrachial vasodilators during IV saline infusion

Other names: Intact

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

The Autonomic Nervous System, Nitric Oxide and TPA Interactions

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2010
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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