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

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

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 Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: endothelial cell collection

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Heather McHatton, MPH, RN; Phone Number: (573) 882-7619; Email: heathermchatton@health.missouri.edu
• Study Contact Backup: Name: Vasavi Shabrish, PhD; Email: v.shabrish@missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri School of Medicine
      • Contact: Vasavi Shabrish; Email: v.shabrish@missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

convenience population of volunteers in mid-Missouri region

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single arm; For blood assay validation and/or reproducibility testing, blood samples will be taken after an overnight fast or after oral glucose or a mixed meal and analyzed. Measurements will be made by: using different assays to determine best conditions of measurement, or repeat testing on different days. Endothelial cells will be collected from a 20-gauge intravenous catheter. One to six 0.025" J-wires will be sequentially inserted into the catheter. These measurements will allow us to determine: the reproducibility and variability of assays used, best timing of blood and endothelial cell collection and best blood volumes and endothelial cell collection wire passes to reliably perform routine assays. For imaging validation, algorithm development, and/or reproducibility testing, participants may undergo DEXA, MRI, or MRS testing to develop or improve analysis algorithms, to evaluate variability of the measurements, or testing different equipment that measure the same variable.

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 variable.; Other Names: DEXA; MRI; MRS; blood testing; mixed meal; oral glucose tolerance testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	through study completion, an average of 10 weeks
Validation and reproducibility testing for endothelial cell collection	endothelial cell quantity collected	through study completion, an average of 10 weeks
Validation and reproducibility testing for mixed meal ingestion	tolerability and palatability of meal type (protein concentration, carbohydrate concentration)	through study completion, an average of 10 weeks
Validation and reproducibility testing for glucose tolerance testing	glucose levels	through study completion, an average of 10 weeks
Validation and reproducibility testing for DEXA	body composition analysis	through study completion, an average of 10 weeks
Validation and reproducibility testing for MRI	body composition analysis	through study completion, an average of 10 weeks
Validation and reproducibility testing for MRS	body composition analysis	through study completion, an average of 10 weeks

Collaborators and Investigators

• Sponsor: Bettina Mittendorfer
• Investigators: Principal Investigator: Bettina Mittendorfer, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2100332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No