RecruitingNCT07083557

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

Sponsor

Bettina Mittendorfer

Enrollment

100 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Heart Failure Sarcopenia Osteoporosis Diabetes Cachexia Hypoparathyroidism Chronic Kidney Disease(CKD)Obesity and Obesity-related Medical Conditions Hyperparathyroidism Osteopenia MASH Ischemic Heart Disease Atherosclerotic Disease Cystic Fibrosis (CF)

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

≥18 and ≤100 years of age
body mass index ≥16.0 and ≤60 kg/m2

Exclusion Criteria8

\<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.

Interventions

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