Status:
COMPLETED
Reference Values for Plasma Catechols
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Healthy Volunteers
Normal Physiology
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Objectives: Plasma levels of catechols have distinct meanings in terms of indicating functions of endogenous catecholamine systems. This Protocol is designed to enable ongoing quality assurance of dia...
Detailed Description
Objective: Plasma levels of catechols have distinct meanings in terms of indicating functions of endogenous catecholamine systems. This protocol is designed to enable ongoing quality assurance of diag...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- The subjects are healthy volunteers 18 years or older who are not pregnant or lactating.
- EXCLUSION CRITERIA:
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- Minors younger than 18 years old are excluded.
- A candidate subject is excluded if, in the judgment of the Principal Investigator, Protocol participation would place the subject at substantially increased acute medical risk. A candidate subject is excluded if, in the opinion of the Principal Investigator, the medical risk outweighs the potential scientific benefit.
- A candidate subject is excluded if there is a disqualifying condition. Examples of disqualifying conditions are hepatic failure, a history of tachyarrhythmias or heart block, symptomatic congestive heart failure, severe anemia, psychosis, refractory ventricular arrhythmias, symptomatic coronary heart disease, diabetes mellitus, or hyperthyroidism. Abnormal screening results may exclude further participation, at the discretion of the Principal Investigator.
- Subjects will be excluded from further participation and referred for medical management, if the systolic blood pressure during supine rest is greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 105 mm Hg.
- Alcohol use disorder.
- A candidate subject is excluded if clinical considerations require that the patient continue treatment with a drug likely to interfere with the scientific results. Examples are acetaminophen, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, adrenoceptor agonists or antagonists, anticoagulants, anticonvulsants, antipsychotics, calcium channel blockers, hypoglycemic agents, digoxin, dopaminergic drugs, monoamine oxidase inhibitors, oral contraceptives, sedatives, steroids, and tricyclic antidepressants. Patients are not to discontinue any medications, just to participate in this study.
- Subjects in whom we feel it would be difficult to insert a catheter into a vein may be excluded.
- Pregnant or lactating women are excluded. To exclude pregnancy, women with child bearing potential have blood testing for pregnancy, with negative results obtained within 1 day of each day of testing.
- Candidate subjects who admit to a history of alcohol addiction and alcohol use disorder are excluded from the study as a whole, but is especially important in the portion of the study involving ingesting red wine.
- Candidate subjects who drink alcohol every day are excluded from the portion of the study involving ingesting red wine.
- People with a history of sulfite allergy are excluded from the portion of the study involving ingestion of red wine.
- Subjects must be at least 21 years old in order to participate in the portion of the study involving ingestion of red wine.
Exclusion
Key Trial Info
Start Date :
March 8 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00267904
Start Date
March 8 2006
End Date
March 18 2022
Last Update
March 29 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892