ClinicalTrials.gg
RecruitingNCT07083557VALDUpdated May 7, 2026

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

An observational study in Obesity and Obesity-related Medical Conditions, Diabetes and Atherosclerotic Disease, sponsored by Bettina Mittendorfer. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Bettina Mittendorfer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 100 is below the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Bettina Mittendorfer is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

convenience population of volunteers in mid-Missouri region

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 and ≤100 years of age
  • ≥16.0 and ≤60 kg/m2

Exclusion criteria

Exclusion Criteria:

  • \<18 and >100 years of age
  • \<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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherEndothelial 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.

06

What researchers measure

Primary outcomes

  1. Evaluation of the validity and reproducibility of insulin results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  2. Validation and reproducibility testing for endothelial cell collection

    endothelial cell quantity collected

    Time frame: through study completion, up to 6 months

  3. Validation and reproducibility testing for mixed meal ingestion

    palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed

    Time frame: through study completion, up to 6 months

  4. Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  5. Validation and reproducibility testing for glucose tolerance testing

    glucose levels (mg/dL) at various time points including fasting, random, and postprandial

    Time frame: through study completion, up to 6 months

  6. Validation and reproducibility testing for DEXA

    body composition analysis (percentage fat and muscle)

    Time frame: through study completion, up to 6 months

  7. Validation and reproducibility testing for MRI

    body composition analysis (percentage fat and muscle)

    Time frame: through study completion, up to 6 months

  8. Validation and reproducibility testing for MRS

    body composition analysis (percentage fat and muscle)

    Time frame: through study completion, up to 6 months

  9. Validation and reproducibility of vascular (endothelial) function test

    non-invasive vascular function test (measured using EndoPat machine)

    Time frame: through study completion, up to 6 months

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

    microscopic characteristics of tissue collected

    Time frame: through study completion, up to 6 months

  11. Validation and reproducibility testing of muscle tissue biopsies

    microscopic characteristics of tissue collected

    Time frame: through study completion, up to 6 months

  12. Evaluation of the validity and reproducibility of C-peptide results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  13. Evaluation of the validity and reproducibility of glucagon results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  14. Evaluation of the validity and reproducibility of free fatty acid level results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  15. Evaluation of the validity and reproducibility of glucose results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  16. Evaluation of the validity and reproducibility of ketone body results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  17. Evaluation of the validity and reproducibility of cytokine results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  18. Evaluation of the validity and reproducibility of adipokine results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  19. Evaluation of the validity and reproducibility of lipid profile results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  20. Evaluation of the validity and reproducibility of urine calcium results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  21. Evaluation of the validity and reproducibility of urine magnesium results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  22. Evaluation of the validity and reproducibility of urine phosphorous results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  23. Evaluation of the validity and reproducibility of urine sodium results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  24. Evaluation of the validity and reproducibility of urine oxalate results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

  25. Evaluation of the validity and reproducibility of urine citrate results in the laboratory environment

    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

    Time frame: through study completion, up to 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07083557
Lead sponsor
Bettina Mittendorfer
Responsible party
Bettina Mittendorfer (Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit, University of Missouri-Columbia) — Sponsor-investigator
First posted
Jul 24, 2025
Start date
Jan 1, 2027 (estimated)
Primary completion
Jul 1, 2030 (estimated)
Completion
Jul 1, 2030 (estimated)
Last update
May 7, 2026

Study contacts

Study coordinator
Contact
ahmc4@health.missouri.edu
573-884-6852
Bettina Mittendorfer, PhD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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