Autonomic Nervous System and Nitric Oxide Interactions

Endothelial Dysfunction Clinical Trial

Official title:

The Autonomic Nervous System, Nitric Oxide and TPA Interactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137253
• Other study ID #: 091489
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2010
• Last updated: February 27, 2018
• Start date: June 2010
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	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	2 hours