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Recruiting NCT06286761

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

— Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endothelial cell collection.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research

Overview

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 (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use 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 we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time.

Interventions

  • Other endothelial cell collection
    Participants may opt to have testing performed including blood sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS 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 vari

Primary outcome measures

  • Validation and reproducibility testing for blood assays [Time frame: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for endothelial cell collection [Time frame: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for mixed meal ingestion [Time frame: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for glucose tolerance testing [Time frame: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for DEXA [Time frame: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for MRI [Time frame: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for MRS [Time frame: through study completion, an average of 10 weeks]

Eligibility criteria

Inclusion criteria

  • ≥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 criteria

  • <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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Missouri School of Medicine — Columbia

Identifiers

NCT: NCT06286761 · 2100332

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗