NCT06286761|Recruiting
Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
VAL
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VAL
Sponsor study identifier
observational
100
1 country
1
Study Start
May 8, 2024
Actual (reported)Primary Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2024
Actual (reported)February 29, 2024
Actual (reported)May 8, 2024
Actual (reported)March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Validation and reproducibility testing for blood assays
insulin, C-peptide, glucagon, substrates (free fatty acids, glucose, ketone bodies) and biomarkers of substrate metabolism (e.g., cytokines and adipokines)
through study completion, an average of 10 weeks
Validation and reproducibility testing for endothelial cell collection
endothelial cell quantity collected
through study completion, an average of 10 weeks
Validation and reproducibility testing for mixed meal ingestion
tolerability and palatability of meal type (protein concentration, carbohydrate concentration)
through study completion, an average of 10 weeks
Validation and reproducibility testing for glucose tolerance testing
glucose levels
through study completion, an average of 10 weeks
Validation and reproducibility testing for DEXA
body composition analysis
through study completion, an average of 10 weeks
Validation and reproducibility testing for MRI
body composition analysis
through study completion, an average of 10 weeks
Validation and reproducibility testing for MRS
body composition analysis
through study completion, an average of 10 weeks
For blood assay validation and/or reproducibility testing, blood samples will be taken after an overnight fast or after oral glucose or a mixed meal and analyzed. Measurements will be made by: using different assays to determine best conditions of measurement, or repeat testing on different days. Endothelial cells will be collected from a 20-gauge intravenous catheter. One to six 0.025" J-wires will be sequentially inserted into the catheter. These measurements will allow us to determine: the reproducibility and variability of assays used, best timing of blood and endothelial cell collection and best blood volumes and endothelial cell collection wire passes to reliably perform routine assays. For imaging validation, algorithm development, and/or reproducibility testing, participants may undergo DEXA, MRI, or MRS testing to develop or improve analysis algorithms, to evaluate variability of the measurements, or testing different equipment that measure the same variable.
Participants may opt to have testing performed including blood sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS to investigate use of different assays, different sample treatment approaches to determine optimal conditions that produce the most accurate and reproducible results, and/or repeat testing on different days or with different equipment that measures the same variable.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
convenience population of volunteers in mid-Missouri region
University of Missouri School of Medicine
Columbia, Missouri, 65212, United States
Bettina Mittendorfer, PhD
University of Missouri-Columbia
First Submitted
February 12, 2024
First Posted
February 29, 2024
Study Start
May 8, 2024
Actual (reported)Primary Completion
March 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 4, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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