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

Official Summary

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 Requirements

• Minimum Age: 18 Years
• Maximum Age: 100 Years

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 100 participants

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 Outcomes

• Evaluation of the validity and reproducibility of insulin results in the laboratory environment (through study completion, up to 6 months)
• Validation and reproducibility testing for endothelial cell collection (through study completion, up to 6 months)
• Validation and reproducibility testing for mixed meal ingestion (through study completion, up to 6 months)
• Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment (through study completion, up to 6 months)
• Validation and reproducibility testing for glucose tolerance testing (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.

Trial Locations

• University of Missouri-Columbia, Columbia, Missouri, United States

Contact Information

• Study coordinator — CONTACT
  Phone: 573-884-6852
  Email: ahmc4@health.missouri.edu

Study Officials

• Bettina Mittendorfer, PhD — PRINCIPAL_INVESTIGATOR
  University of Missouri-Columbia

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