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Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)

ConditionsObesity and Obesity-related Medical ConditionsDiabetesAtherosclerotic DiseaseHeart FailureMASHSarcopeniaOsteoporosisHyperparathyroidismHypoparathyroidismIschemic Heart DiseaseCystic Fibrosis (CF)Chronic Kidney Disease(CKD)OsteopeniaCachexia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorBettina Mittendorfer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 and ≤100 years of age

body mass index ≥16.0 and ≤60 kg/m2

Disqualifiers

<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

Trial population

convenience population of volunteers in mid-Missouri region

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endothelial cell collection

    Other intervention

    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 results, and/or repeat testing on different days or with different equipment that measures the same variable.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Evaluation of the validity and reproducibility of insulin results in the laboratory environment

Comparison of insulin results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations

Time frame
through study completion, up to 6 months
2

Validation and reproducibility testing for endothelial cell collection

endothelial cell quantity collected

Time frame
through study completion, up to 6 months
3

Validation and reproducibility testing for mixed meal ingestion

palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed

Time frame
through study completion, up to 6 months
4

Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment

Comparison of urinalysis results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations

Time frame
through study completion, up to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bettina Mittendorfer

Lead sponsor

University of Missouri-Columbia

Sponsor institution

Source ClinicalTrials.gov
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