Validation of Lab Tests for Metabolism Research

This observational study aims to check the accuracy and consistency of various lab tests, equipment, and procedures used in metabolism research at the University of Missouri. This includes methods like blood assays, endothelial cell collection (gathering cells from the lining of blood vessels), and mixed meal ingestion (eating a specific meal to see how your body processes it). The goal is to ensure high-quality research on conditions like obesity, pre-diabetes, and type 2 diabetes. You may be eligible if you are between 18 and 75 years old, have a body mass index (BMI) between 18.5 and 45, and meet certain health criteria regarding your weight, exercise, and blood sugar levels. The study will measure the accuracy and consistency of these tests over an average of 10 weeks.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not testing a new treatment but rather evaluating existing research methods.
What's involved
Participants may choose to have blood samples taken, an intravenous catheter (IV) placed for endothelial cell collection, an oral glucose tolerance test, consume a test meal, and have imaging like MRI, DEXA, or MRS.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for validation and reproducibility testing are measured through study completion, which is an average of 10 weeks.

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NCT06286761

Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)

Recruiting
Not specifiedAges 18–75Observational
Bettina Mittendorfer
~100 participants
Updated 2026-08-04 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
Validation and reproducibility testing for blood assays
Measured over through study completion, an average of 10 weeks
+6 more outcomes measured
Obesity
1 sites across 1 states
Missouri1
  • Bettina Mittendorfer, PhD · PRINCIPAL_INVESTIGATOR · University of Missouri-Columbia

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Eligibility criteria

Inclusion

≥18 and ≤75 years of age
body mass index ≥18.5 and ≤45 kg/m2
Weight stable (i.e., ≤3% change)
≤150 min of structured exercise/week for at least 2 months before entering the study
Blood glucose: \< 126 mg/dl fasted, \< 200 mg/dl with 2 hour oral glucose tolerance testing
Hemoglobin A1C (HbA1C) ≤6.5%
Dyslipidemia triglycerides ≥125 mg/dL
No chronic kidney disease
Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed
No intolerance or allergies to study diet ingredients
No excessive alcohol or tobacco consumption

Exclusion

\<18 and \>75 years of age
body mass index \<18.5 or \>45 kg/m2
history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for \<5 years, dementia, chronic kidney disease)
allergies or intolerances to meal ingredients, vegans or vegetarians
use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc)
take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements)
engaged in regular structured exercise \>150 min per week
alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances
pregnant women
persons who use tobacco
prisoners
the inability to grant voluntary informed consent.
  • Validation and reproducibility testing for blood assaysthrough study completion, an average of 10 weeks

    insulin, C-peptide, glucagon, substrates (free fatty acids, glucose, ketone bodies) and biomarkers of substrate metabolism (e.g., cytokines and adipokines)

  • Validation and reproducibility testing for endothelial cell collectionthrough study completion, an average of 10 weeks

    endothelial cell quantity collected

  • Validation and reproducibility testing for mixed meal ingestionthrough study completion, an average of 10 weeks

    tolerability and palatability of meal type (protein concentration, carbohydrate concentration)

  • Validation and reproducibility testing for glucose tolerance testingthrough study completion, an average of 10 weeks

    glucose levels

  • Validation and reproducibility testing for DEXAthrough study completion, an average of 10 weeks

    body composition analysis

  • Validation and reproducibility testing for MRIthrough study completion, an average of 10 weeks

    body composition analysis

  • Validation and reproducibility testing for MRSthrough study completion, an average of 10 weeks

    body composition analysis