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

Bettina Mittendorfer100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Obesity

Interventions

endothelial cell collectionOTHER

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 variable.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Validation and reproducibility testing for blood assays

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