Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
(VAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to ensure the accuracy and reliability of tools and methods used to study metabolism and chronic diseases like obesity and diabetes. Participants will test lab processes, such as blood tests and imaging scans, to confirm consistent results. Ideal candidates maintain a stable weight, do not follow a high-protein, vegan, or vegetarian diet, and engage in moderate exercise (less than 150 minutes a week). Participants should not have chronic kidney disease or significant allergies to study diet ingredients.
As an unphased trial, participants contribute to advancing research methods and improving future studies.
Will I have to stop taking my current medications?
The trial requires that you do not use medications that could affect the study results, like anti-inflammatories or immune modulators. If you're taking these, you may need to stop, but the protocol doesn't specify a washout period.
What prior data suggests that these laboratory assays, catheter insertion techniques, and devices are safe for use in research on chronic diseases?
Research has shown that cells lining blood vessels, known as endothelial cells, are often used in studies on blood vessel growth, cancer treatment, and wound healing. This suggests they are generally safe for medical research. Collecting these cells involves inserting a small wire into a vein, a common and typically low-risk procedure. While specific safety data from these studies is not available, similar procedures are usually safe. Participants should discuss any concerns with the trial team to understand potential risks better.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to refine and improve the techniques used for metabolism research. Unlike current methods, this trial is focused on understanding the reproducibility and variability of various assays and imaging techniques such as DEXA, MRI, and MRS. By testing different conditions and equipment, the trial seeks to develop new algorithms and determine the best practices for blood and endothelial cell collection, which could lead to more accurate and reliable metabolic measurements. This could pave the way for breakthroughs in understanding and treating metabolic conditions, making it a crucial step forward in medical research.
What evidence suggests that these laboratory assays, devices, and techniques are effective for chronic disease research?
Research has shown that certain cells in the blood, called circulating endothelial cells (CECs), can indicate damage to blood vessels, which is crucial in conditions like heart attacks. Studies have found that CECs effectively reveal changes in blood vessels. These cells can aid in the early diagnosis of heart and blood vessel diseases. In this trial, participants will undergo endothelial cell collection to validate and enhance diagnostic tests. By collecting and studying these cells, scientists aim to improve the accuracy and reliability of diagnostic tests. This could lead to a better understanding and management of diseases related to blood vessel damage.678910
Who Is on the Research Team?
Bettina Mittendorfer, PhD
Principal Investigator
University of Missouri-Columbia
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Validation and Reproducibility Testing
Participants undergo various laboratory assays, imaging tests, and catheter insertions to validate and test the reproducibility of these methods.
Follow-up
Participants are monitored for safety and effectiveness after testing
What Are the Treatments Tested in This Trial?
Interventions
- Endothelial Cell Collection
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bettina Mittendorfer
Lead Sponsor
Citations
Reproducibility of circulating endothelial cell enumeration ...
We examined the reproducibility of circulating endothelial cells (CEC) enumeration and activation among youth. CECs from 151 youth were measured at baseline ...
Circulating endothelial cells as biomarker for ...
With the improved sensitivity, our validated assay opens the perspective to a future use as additional diagnostic tool for early detection of cardiovascular ...
Study Details | NCT07083557 | Routine Validation and ...
This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by ...
Comparative Analysis of Blood‐Derived Endothelial Cells ...
This study provides evidence that blood‐derived endothelial cells are suitable patient‐specific alternatives to commercially available primary ...
Detection and Validation of Circulating Endothelial Cells, a ...
Circulating endothelial cells (CECs) are markers of vascular damage that have clinical relevance in many diseases, including acute myocardial infarction (AMI).
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bioscience.lonza.com
bioscience.lonza.com/lonza_bs/US/en/p/PDFdocument?productCode=000000000000185014&reptype=MSDS&rvlid=US&iso=ENHuman Dermal Microvascular Endothelial Cells, Adult
Hygiene measures. : Handle in accordance with good industrial hygiene and safety practice. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES.
Endothelial Cells
Endothelial cells line blood vessels, acting as a filter. They are used in studies of angiogenesis, cancer therapy, and wound healing.
SAFETY DATA SHEET
General hygiene considerations. Handle in accordance with good industrial hygiene and safety practice. 9. PHYSICAL AND CHEMICAL PROPERTIES.
9.
promocell.com
promocell.com/us_en/endothelial-cell-growth-medium.html?srsltid=AfmBOoq0AqURfv9KeS0RiGDv1vWCFQyRGaFko8SMS1eflfn8gwOwPCGWEndothelial Cell Growth Medium | PromoCell
Endothelial Cell Growth Medium is a low-serum (2% V/V) medium optimized for the cultivation of endothelial cells from large blood vessels.
Endothelial Cell Growth Media CCM027
The safety and efficacy of this product in diagnostic or other clinical uses has not been established. This reagent should not be used beyond the expiration ...
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