Autonomic Nervous System and Nitric Oxide Interactions
This study is currently recruiting participants.
Verified April 2012 by Vanderbilt University
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Alfredo Gamboa, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01137253
First received: June 1, 2010
Last updated: November 8, 2012
Last verified: April 2012
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Purpose
The investigators are interested in the role of the autonomic nervous system in the regulation of endothelial function. In particular, the investigators will study how endothelial function changes during autonomic withdrawal.
| Condition | Intervention |
|---|---|
|
Endothelial Dysfunction |
Drug: Trimethaphan Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
| Official Title: | The Autonomic Nervous System, Nitric Oxide and TPA Interactions |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Nitric oxide
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Endothelial Function [ Time Frame: 2 hours ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Metabolic Parameters [ Time Frame: 2 hours ] [ Designated as safety issue: No ]During Insulin Clamp
- Flow mediated dilatation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Changes in brachial artery diameter will be determined before and after autonomic blockade
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Autonomic Withdrawal
Response to intrabrachial vasodilators during autonomic withdrawal
|
Drug: Trimethaphan
Trimethaphan 4 mg/min IV, for the duration of the study (approximately 2 hours)
|
|
Placebo Comparator: Autonomic Intact
Response to intrabrachial vasodilators during saline intravenous (IV) infusion
|
Drug: Placebo
Response to intrabrachial vasodilators during IV saline infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 metabolic syndrome.
- 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 > 30Kg/m2.
Participants will be enrolled if they met at least three of the following criteria for metabolic syndrome (Expert panel, Jama 2001):
- Waist circumference >102 cm in men and >88 cm in women
- High fasting blood sugar (>110 mg%)
- Triglyceride levels >150 mg%
- Low high-density lipoprotein (HDL) cholesterol (<40 mg% for men; <50 mg% for women)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137253
Contacts
| Contact: Ginnie Farley | 615-322-0083 | ginnie.farley@vanderbilt.edu |
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Sub-Investigator: Italo Biaggioni, MD | |
Sponsors and Collaborators
Vanderbilt University
More Information
No publications provided
| Responsible Party: | Alfredo Gamboa, Research Assistant Professor, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01137253 History of Changes |
| Other Study ID Numbers: | 091489 |
| Study First Received: | June 1, 2010 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
Nitric Oxide Autonomic Nervous System |
Additional relevant MeSH terms:
|
Nitric Oxide Trimethaphan Trimethaphan camsylate Vasodilator Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers |
Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Cardiovascular Agents Protective Agents Adjuvants, Anesthesia Central Nervous System Agents Antihypertensive Agents Ganglionic Blockers Nicotinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013