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

NCT ID: NCT07083557

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-07-01

Brief 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bettina Mittendorfer

OTHER

Sponsor Role: lead

Responsible Party

Bettina Mittendorfer

Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bettina Mittendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study coordinator

Role: CONTACT

ahmc4@health.missouri.edu

573-884-6852

Facility Contacts

Study coordinator

Role: primary

ahmc4@health.missouri.edu

573-884-6852

Other Identifiers

2127348

Identifier Type: -

Identifier Source: org_study_id