Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267904
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2005-12-21
Brief Title:
Reference Values for Plasma Catechols
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Reference Values for Plasma Catechols
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 iv 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
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 iv 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
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 diagnostic and research assays of catechols and their metabolites and to identify possible influences of dietary constituents and conditions of sampling
Study PopulationThe study population is Healthy Volunteers HVs
Design Arm venous blood is drawn via an indwelling iv catheter from HVs to obtain quality control plasma Levels of catechols and their metabolites are related to dietary influences eg 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
Study PopulationThe study population is Healthy Volunteers HVs
Design Arm venous blood is drawn via an indwelling iv catheter from HVs to obtain quality control plasma Levels of catechols and their metabolites are related to dietary influences eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0047 | None | None | None |