Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endothelial cell collection.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions, Diabetes, Atherosclerotic Disease, Heart Failure. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses 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 the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.
Interventions
- Other Endothelial cell collection
Participants may opt to have testing performed including blood sampling, urine sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS, having adipose (fat) or muscle biopsies, or non-invasive endothelial function testing to investigate use of different assays, different sample treatment approaches to determine optimal conditions that produce the most accurate and reproducible r
Primary outcome measures
- Evaluation of the validity and reproducibility of insulin results in the laboratory environment [Time frame: through study completion, up to 6 months]
- Validation and reproducibility testing for endothelial cell collection [Time frame: through study completion, up to 6 months]
- Validation and reproducibility testing for mixed meal ingestion [Time frame: through study completion, up to 6 months]
- Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment [Time frame: through study completion, up to 6 months]
- Validation and reproducibility testing for glucose tolerance testing [Time frame: through study completion, up to 6 months]
- Validation and reproducibility testing for DEXA [Time frame: through study completion, up to 6 months]
- Validation and reproducibility testing for MRI [Time frame: through study completion, up to 6 months]
- Validation and reproducibility testing for MRS [Time frame: through study completion, up to 6 months]
- Validation and reproducibility of vascular (endothelial) function test [Time frame: through study completion, up to 6 months]
- Validation and reproducibility of adipose (fat) tissue biopsy [Time frame: through study completion, up to 6 months]
Eligibility criteria
Inclusion criteria
- ≥18 and ≤100 years of age
- body mass index ≥16.0 and ≤60 kg/m2
Exclusion criteria
- <18 and >100 years of age
- body mass index <16.0 or >60 kg/m2
- allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians
- use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay/techniques being evaluated
- engaged in regular structured exercise >150 min per week unless needed for validation of the assay/technique being evaluated
- significant organ system dysfunction or diseases, except those that are sought for validation of the assay/technique being evaluated
- alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay/technique being evaluated
- pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Missouri-Columbia — Columbia
Identifiers
NCT: NCT07083557 · 2127348