NCT07083557 · Bettina Mittendorfer
Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
(VALD)
What this study is about
The purpose of this research study is to validate (check the accuracy of) laboratory assays, given through a vein (IV) 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.
View original scientific description
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.
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 results, and/or repeat testing on different days or with different equipment that measures the same variable.
Primary outcome measures
Evaluation of the validity and reproducibility of insulin results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of insulin results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Validation and reproducibility testing for endothelial cell collection
Time frame: through study completion, up to 6 months
endothelial cell quantity collected
Validation and reproducibility testing for mixed meal ingestion
Time frame: through study completion, up to 6 months
palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed
Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urinalysis results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Validation and reproducibility testing for glucose tolerance testing
Time frame: through study completion, up to 6 months
glucose levels (mg/dL) at various time points including fasting, random, and postprandial
Validation and reproducibility testing for DEXA
Time frame: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility testing for MRI
Time frame: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility testing for MRS
Time frame: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility of vascular (endothelial) function test
Time frame: through study completion, up to 6 months
non-invasive vascular function test (measured using EndoPat machine)
Validation and reproducibility of adipose (fat) tissue biopsy
Time frame: through study completion, up to 6 months
microscopic characteristics of tissue collected
Validation and reproducibility testing of muscle tissue biopsies
Time frame: through study completion, up to 6 months
microscopic characteristics of tissue collected
Evaluation of the validity and reproducibility of C-peptide results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of C-peptide results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of glucagon results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of glucagon results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of free fatty acid level results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of free fatty acid level results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of glucose results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of glucose results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of ketone body results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of ketone body results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of cytokine results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of cytokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of adipokine results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of adipokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of lipid profile results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of lipid profile results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine calcium results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine calcium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine magnesium results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine magnesium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine phosphorous results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine phosphorous results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine sodium results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine sodium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine oxalate results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine oxalate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine citrate results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine citrate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Columbia, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations