Reference Values for Plasma Catechols
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/17/2019 |
| Start Date: | December 15, 2005 |
| Contact: | Tereza Jenkins |
| Email: | jenkinst@ninds.nih.gov |
| Phone: | (301) 496-1115 |
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 diagnostic and research assays of catechols and their metabolites and to
identify possible influences of demographic and anthropometric factors, dietary constituents,
and conditions of sampling on reference values.
Study Populations: The study population is healthy volunteers and people who are obese or
have untreated hypertension.
Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers
across demographic and anthropometric spectra (age, gender, skin color, ethnicity, body mass,
adiposity), to obtain quality control plasma and establish reference values for plasma levels
of catechols and their metabolites. Non-invasive physiological measures are obtained
concurrently. Levels of catechols and their metabolites are related to results of common
clinical pathology tests. Subgroups of subjects are tested more than once, to assess dietary
influences (cereal with milk, coffee) and conditions of sampling (temperature at the skin).
Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control
plasma. The main experimental outcome measures are plasma concentrations of catechols and
their metabolites, non-invasive physiological measures, and results of common clinical
pathology tests. Subject groups are compared with respect to the above demographic and
anthropometric factors. Effects of the experimental manipulations are assessed within
subjects
functions of endogenous catecholamine systems. This Protocol is designed to enable ongoing
quality assurance of diagnostic and research assays of catechols and their metabolites and to
identify possible influences of demographic and anthropometric factors, dietary constituents,
and conditions of sampling on reference values.
Study Populations: The study population is healthy volunteers and people who are obese or
have untreated hypertension.
Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers
across demographic and anthropometric spectra (age, gender, skin color, ethnicity, body mass,
adiposity), to obtain quality control plasma and establish reference values for plasma levels
of catechols and their metabolites. Non-invasive physiological measures are obtained
concurrently. Levels of catechols and their metabolites are related to results of common
clinical pathology tests. Subgroups of subjects are tested more than once, to assess dietary
influences (cereal with milk, coffee) and conditions of sampling (temperature at the skin).
Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control
plasma. The main experimental outcome measures are plasma concentrations of catechols and
their metabolites, non-invasive physiological measures, and results of common clinical
pathology tests. Subject groups are compared with respect to the above demographic and
anthropometric factors. Effects of the experimental manipulations are assessed within
subjects
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 diagnostic and research assays of catechols and their metabolites and to
identify possible influences of dietary constituents and conditions of sampling.
Study Populations: The study population is healthy volunteers.
Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers, to
obtain quality control plasma. Levels of catechols and their metabolites are related to
dietary influences (cereal with milk, coffee, olives) and conditions of sampling (temperature
at the skin).
Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control
plasma. The main experimental outcome measures are plasma concentrations of catechols and
their metabolites, physiological measures, and results of common clinical pathology tests.
Effects of the experimental manipulations are assessed within subjects.
functions of endogenous catecholamine systems. This Protocol is designed to enable ongoing
quality assurance of diagnostic and research assays of catechols and their metabolites and to
identify possible influences of dietary constituents and conditions of sampling.
Study Populations: The study population is healthy volunteers.
Design: Arm venous blood is drawn via an indwelling i.v. catheter from healthy volunteers, to
obtain quality control plasma. Levels of catechols and their metabolites are related to
dietary influences (cereal with milk, coffee, olives) and conditions of sampling (temperature
at the skin).
Outcome Measures: The main non-experimental outcome is an ongoing pool of quality control
plasma. The main experimental outcome measures are plasma concentrations of catechols and
their metabolites, physiological measures, and results of common clinical pathology tests.
Effects of the experimental manipulations are assessed within subjects.
- INCLUSION CRITERIA:
The subjects are healthy volunteers 18 years or older who are not pregnant or lactating.
EXCLUSION CRITERIA:
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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