Autonomic Nervous System and Nitric Oxide Interactions

Vanderbilt University

Status and phase: Completed; Phase 1

Conditions: Endothelial Dysfunction

Treatments: Drug: Trimethaphan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01137253

091489

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups, including a placebo group

Trimethaphan

Experimental group

Description:

Response to intrabrachial vasodilators during autonomic withdrawal

Treatment:

Drug: Trimethaphan

Placebo

Placebo Comparator group

Description:

Response to intrabrachial vasodilators during saline intravenous (IV) infusion

Treatment:

Drug: Placebo