Reference Values for Plasma Catechols

Healthy Volunteers Clinical Trial

Official title:

Reference Values for Plasma Catechols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267904
• Other study ID #: 060047
• Secondary ID: 06-N-0047
• Status: Completed
• Phase: Phase 1
• Start date: March 8, 2006
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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 diagnostic and research assays of catechols and their metabolites and to identify possible influences of dietary constituents and conditions of sampling.

Study Population:The study population is Healthy Volunteers (HVs).

Design: Arm venous blood is drawn via an indwelling i.v. catheter from HVs to obtain quality control plasma. Levels of catechols and their metabolites are related to dietary influences (e.g., coffee, olives, banana) and conditions of sampling (temperature at the skin) by repeated measurements in the same subjects over time.

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 and physiological measures, and results of common clinical pathology tests. Effects of the experimental manipulations are assessed within subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 18, 2022
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Normal Physiology

Intervention

Other:
• Coffee
Caffeinated coffee and decaffeinated coffee ingestion
• Banana
Banana ingestion
• Olives
Olives ingestion
• Temp. manip.
Manipulate temperature at skin of the back

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Eisenhofer G, Goldstein DS, Stull R, Keiser HR, Sunderland T, Murphy DL, Kopin IJ. Simultaneous liquid-chromatographic determination of 3,4-dihydroxyphenylglycol, catecholamines, and 3,4-dihydroxyphenylalanine in plasma, and their responses to inhibition of monoamine oxidase. Clin Chem. 1986 Nov;32(11):2030-3. — View Citation

Goldstein DS, Lenders JW, Kaler SG, Eisenhofer G. Catecholamine phenotyping: clues to the diagnosis, treatment, and pathophysiology of neurogenetic disorders. J Neurochem. 1996 Nov;67(5):1781-90. Review. — View Citation

Holmes C, Eisenhofer G, Goldstein DS. Improved assay for plasma dihydroxyphenylacetic acid and other catechols using high-performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Appl. 1994 Mar 4;653(2):131-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pool of quality control plasma	The main non-experimental outcome is an ongoing pool of quality control plasma.	One time (over 1-4 outpatient visits)
Primary	Plasma concentrations of catechols and their metabolites and physiological measure	The main experimental outcome measures are plasma concentrations of catechols and their metabolites and physiological measures, and results of common clinical pathology tests. Effects of the experimental manipulations are assessed within subjects.	One time (over 1-4 outpatient visits)

External Links

•   NIH Clinical Center Detailed Web Page