Validating lab assays, IV catheter techniques, and devices for endocrine, cardiometabolic, and musculoskeletal conditions
Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
This project will test whether laboratory assays, IV catheter methods, and equipment give consistent, reliable results in adults with or without obesity-related, metabolic, or musculoskeletal conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT07083557 on ClinicalTrials.gov |
What this trial studies
This observational project compares results from current and new laboratory assays, intravenous catheter insertions, and equipment to determine reproducibility. Participants who are healthy or who have obesity, diabetes, atherosclerotic disease, heart failure, or MASH will undergo repeated measurements to see if the same results are achieved each time. Procedures may include blood draws, endothelial cell collection, standardized meals, and use of different devices or assays, with exclusions for medications, diets, or behaviors that could interfere. The work is conducted at the University of Missouri-Columbia to ensure accurate, repeatable testing for chronic disease and metabolism research.
Who should consider this trial
Good fit: Adults aged 18–100 with a body mass index between 16.0 and 60 kg/m2 who are healthy or have relevant endocrine, cardiometabolic, or musculoskeletal conditions and who are not taking medications or supplements that interfere with the tested assays may qualify.
Not a fit: People who are pregnant, current smokers, prisoners, use interfering medications or supplements, have significant organ dysfunction (unless sought for validation), or cannot attend in-person procedures are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this work will increase confidence that lab tests and techniques produce accurate, repeatable results, improving the quality of research and supporting better clinical decisions.
How similar studies have performed: Similar validation and reproducibility efforts are common and have confirmed reliability for many established assays, although newer devices and methods often require fresh testing.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbia, Missouri
- University of Missouri-Columbia — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Bettina Mittendorfer, PhD — University of Missouri-Columbia
- Study coordinator: Study coordinator
- Email: ahmc4@health.missouri.edu
- Phone: 573-884-6852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.