Study to Validate Lab Tests for Chronic Diseases

This study, called VALD, aims to check the accuracy and consistency (reproducibility) of lab tests and research methods used for conditions like obesity, diabetes, and heart disease at the University of Missouri. As technology changes, it's important to make sure new and old testing methods give reliable results. You might be asked to provide blood or urine samples, have an intravenous catheter (a small tube in your vein) placed for endothelial cell collection, take an oral glucose tolerance test, eat a special meal, or have imaging like MRI or DEXA scans. Some participants may also have fat or muscle biopsies. The study will evaluate the accuracy of insulin results, endothelial cell collection, and mixed meal ingestion for up to 6 months. Adults aged 18 to 100 with a body mass index (BMI) between 16 and 60 kg/m2 can join. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 100 participants. It is not specified if it is randomized or blinded.
What's involved
You may have blood and urine tests, an intravenous catheter placement, an oral glucose tolerance test, consume a test meal, have imaging (MRI, DEXA, MRS), or have fat or muscle biopsies. These activities will occur over a period of up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07083557

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

Recruiting
Not specifiedAges 18+Observational
Bettina Mittendorfer
~100 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Endothelial cell collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of the validity and reproducibility of insulin results in the laboratory environment
Measured over through study completion, up to 6 months
+24 more outcomes measured
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
1 sites across 1 states
Missouri1
  • Bettina Mittendorfer, PhD · PRINCIPAL_INVESTIGATOR · University of Missouri-Columbia

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Eligibility criteria

Inclusion

≥18 and ≤100 years of age
body mass index ≥16.0 and ≤60 kg/m2

Exclusion

\<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.
  • Evaluation of the validity and reproducibility of insulin results in the laboratory environmentthrough 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 collectionthrough study completion, up to 6 months

    endothelial cell quantity collected

  • Validation and reproducibility testing for mixed meal ingestionthrough 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 environmentthrough 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 testingthrough study completion, up to 6 months

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

  • Validation and reproducibility testing for DEXAthrough study completion, up to 6 months

    body composition analysis (percentage fat and muscle)

  • Validation and reproducibility testing for MRIthrough study completion, up to 6 months

    body composition analysis (percentage fat and muscle)

  • Validation and reproducibility testing for MRSthrough study completion, up to 6 months

    body composition analysis (percentage fat and muscle)

  • Validation and reproducibility of vascular (endothelial) function testthrough study completion, up to 6 months

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

  • Validation and reproducibility of adipose (fat) tissue biopsythrough study completion, up to 6 months

    microscopic characteristics of tissue collected

  • Validation and reproducibility testing of muscle tissue biopsiesthrough study completion, up to 6 months

    microscopic characteristics of tissue collected

  • Evaluation of the validity and reproducibility of C-peptide results in the laboratory environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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 environmentthrough 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