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

Recruiting

• Conditions: Obesity
• Interventions: Other: endothelial cell collection

• Registration Number: NCT06286761
• Lead Sponsor: Bettina Mittendorfer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-29
• Study Start: 2024-05-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	endothelial cell collection	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri School of Medicine; 🇺🇸 Columbia, Missouri, United States