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

ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBettina Mittendorfer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥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

Disqualifiers

<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

Trial population

convenience population of volunteers in mid-Missouri region

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • endothelial cell collection

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single arm1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
through study completion, an average of 10 weeks
2

Validation and reproducibility testing for endothelial cell collection

endothelial cell quantity collected

Time frame
through study completion, an average of 10 weeks
3

Validation and reproducibility testing for mixed meal ingestion

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

Time frame
through study completion, an average of 10 weeks
4

Validation and reproducibility testing for glucose tolerance testing

glucose levels

Time frame
through study completion, an average of 10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bettina Mittendorfer

Lead sponsor

University of Missouri-Columbia

Sponsor institution