Autonomic Nervous System and Nitric Oxide Interactions

NCT01137253 — Phase 1, Completed, 21 participants, Vanderbilt University

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The Autonomic Nervous System, Nitric Oxide and TPA Interactions

Registry	NCT01137253
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: single, other
Enrollment	21 (Actual)
Sponsor	Vanderbilt University (Other)
Conditions	Endothelial Dysfunction
Interventions	Trimethaphan, Placebo (Drug)
Dates	start 2010-06-01, primary completion 2017-01-01, completion 2017-01-01, first posted 2010-06-04, last updated 2018-02-28
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Trimethaphan	Experimental	Drug: Trimethaphan	Response to intrabrachial vasodilators during autonomic withdrawal
Placebo	Placebo comparator	Drug: Placebo	Response to intrabrachial vasodilators during saline intravenous (IV) infusion

Trimethaphan (Drug), also known as Blocked: Trimethaphan 4 mg/min IV, for the duration of the study (approximately 2 hours)
Placebo (Drug), also known as Intact: Response to intrabrachial vasodilators during IV saline infusion

+Outcome measures

Primary outcomes

Endothelial Function [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

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Vanderbilt University Medical Center	Nashville, Tennessee	United States