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NCT Number: NCT07083557

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

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.

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Atherosclerotic Disease Atrophy Body Weight Body Weight Changes Bone Diseases Bone Diseases, Metabolic Cachexia Cardiovascular Diseases Chronic Disease Chronic Kidney Disease(CKD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis (CF) Diabetes Diabetes Mellitus Digestive System Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperparathyroidism Hypoparathyroidism Infant, Newborn, Diseases Ischemic Heart Disease Kidney Diseases Lung Diseases MASH Male Urogenital Diseases Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteopenia Osteoporosis Overnutrition Overweight Pancreatic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Sarcopenia Signs and Symptoms Thinness Urogenital Diseases Urologic Diseases Vascular Diseases Weight Loss

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location status: Recruiting

Location contact

Study coordinator

CONTACT

[email protected]

573-884-6852

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endothelial cell collection

Other

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 outcomes

  1. 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

  2. Validation and reproducibility testing for endothelial cell collection

    Time frame: through study completion, up to 6 months

    endothelial cell quantity collected

  3. 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

  4. 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

  5. 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

  6. Validation and reproducibility testing for DEXA

    Time frame: through study completion, up to 6 months

    body composition analysis (percentage fat and muscle)

  7. Validation and reproducibility testing for MRI

    Time frame: through study completion, up to 6 months

    body composition analysis (percentage fat and muscle)

  8. Validation and reproducibility testing for MRS

    Time frame: through study completion, up to 6 months

    body composition analysis (percentage fat and muscle)

  9. 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)

  10. Validation and reproducibility of adipose (fat) tissue biopsy

    Time frame: through study completion, up to 6 months

    microscopic characteristics of tissue collected

  11. Validation and reproducibility testing of muscle tissue biopsies

    Time frame: through study completion, up to 6 months

    microscopic characteristics of tissue collected

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Study coordinator

CONTACT

[email protected]

573-884-6852

Sponsors and collaborators

Lead sponsor

Bettina Mittendorfer

Other

Registry information

Acronym: VALD

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Jul 24, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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