Autonomic Nervous System and Nitric Oxide Interactions

The Autonomic Nervous System, Nitric Oxide and TPA Interactions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01137253

Enrollment

Registered

2010-06-04

Start date

2010-06-30

Completion date

2017-01-31

Last updated

2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction

Keywords

Nitric Oxide, Autonomic Nervous System

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.

Interventions

DRUGTrimethaphan

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

DRUGPlacebo

Response to intrabrachial vasodilators during IV saline infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026