Reference Values for Plasma Catechols

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT00267904
First received: December 21, 2005
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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


Condition
Catecholamine
Healthy Volunteers
Normal Physiology

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Reference Values for Plasma Catechols

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Plasma catechols [ Time Frame: Up to 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2005
Detailed Description:

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) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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. Hypertensives are excluded from the part of the study about coffee drinking.

Alcohol addiction.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267904

Contacts
Contact: Tereza Jenkins (301) 496-1115 jenkinst@ninds.nih.gov
Contact: David S Goldstein, M.D. (301) 496-2103 goldsteind@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: David S Goldstein, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00267904     History of Changes
Other Study ID Numbers: 060047, 06-N-0047
Study First Received: December 21, 2005
Last Updated: July 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Normal Physiology
Catecholamines
Catechols
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on July 22, 2014