Recruiting

Validation & Reproducibility

Sponsor:

Bettina Mittendorfer

Code:

NCT07083557

Conditions

Obesity and Obesity-related Medical Conditions

Diabetes

Atherosclerotic Disease

Heart Failure

MASH

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Endothelial cell collection

Study Details

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

Study ID

NCT07083557

Start date

Jan 1, 2027

Status verified date

Apr, 2026

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Evaluation of the validity and reproducibility of insulin results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing for endothelial cell collection [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing for mixed meal ingestion [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing for glucose tolerance testing [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing for DEXA [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing for MRI [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing for MRS [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility of vascular (endothelial) function test [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility of adipose (fat) tissue biopsy [ Time Frame: through study completion, up to 6 months ]
  • Validation and reproducibility testing of muscle tissue biopsies [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of C-peptide results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of glucagon results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • 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 ]
  • Evaluation of the validity and reproducibility of glucose results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of ketone body results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of cytokine results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of adipokine results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of lipid profile results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urine calcium results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urine magnesium results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urine phosphorous results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urine sodium results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urine oxalate results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]
  • Evaluation of the validity and reproducibility of urine citrate results in the laboratory environment [ Time Frame: through study completion, up to 6 months ]

Central Contacts and Locations

Central contacts

Study coordinator

573-884-6852ahmc4@health.missouri.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Study coordinator

573-884-6852ahmc4@health.missouri.edu

More Information

Sponsor

Bettina Mittendorfer

Last update posted

May 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bettina Mittendorfer on 2026-05-07.