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

Bettina Mittendorfer

Status: Enrolling

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

Treatments: Other: Endothelial cell collection

Study type: Observational

Funder types: Other

Identifiers

NCT07083557

2127348

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.