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Single arm for Obesity (VAL Trial)

N/A
Recruiting
Led By Bettina Mittendorfer, PhD
Research Sponsored by Bettina Mittendorfer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 10 weeks
Awards & highlights

VAL Trial 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.

VAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Validation and reproducibility testing for DEXA
Validation and reproducibility testing for MRI
Validation and reproducibility testing for MRS
+4 more

VAL Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Bettina MittendorferLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Obesity
60 Patients Enrolled for Obesity
Bettina Mittendorfer, PhDPrincipal InvestigatorUniversity of Missouri-Columbia
8 Previous Clinical Trials
478 Total Patients Enrolled
2 Trials studying Obesity
136 Patients Enrolled for Obesity
~67 spots leftby Mar 2028