Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Use… (NCT06286761) | Clinical Trial Compass
RecruitingNot Applicable
Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
United States100 participantsStarted 2024-05-08
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validation and reproducibility testing for blood assays
Timeframe: through study completion, an average of 10 weeks
2
Validation and reproducibility testing for endothelial cell collection
Timeframe: through study completion, an average of 10 weeks
3
Validation and reproducibility testing for mixed meal ingestion
Timeframe: through study completion, an average of 10 weeks
4
Validation and reproducibility testing for glucose tolerance testing
Timeframe: through study completion, an average of 10 weeks
5
Validation and reproducibility testing for DEXA
Timeframe: through study completion, an average of 10 weeks
6
Validation and reproducibility testing for MRI
Timeframe: through study completion, an average of 10 weeks
7
Validation and reproducibility testing for MRS
Timeframe: through study completion, an average of 10 weeks