ObesityVALNCT06286761
Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)
An observational study of Obesity, run by Bettina Mittendorfer at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- endothelial cell collection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: convenience population of volunteers in mid-Missouri region
Who may be able to join
- ≥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%
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- 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
Who cannot join
- <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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vasavi Shabrish, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri School of Medicine
Columbia, Missouri, 65212
Vasavi Shabrish, v.shabrish@missouri.edu
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- endothelial cell collection
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endothelial cell collectionOther
Also called MRI, DEXA, MRS, blood testing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: endothelial cell collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 10 weeks
Validation and reproducibility testing for endothelial cell collection
endothelial cell quantity collected
Measured: 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)
Measured: through study completion, an average of 10 weeks
Validation and reproducibility testing for glucose tolerance testing
glucose levels
Measured: through study completion, an average of 10 weeks
Validation and reproducibility testing for DEXA
body composition analysis
Measured: through study completion, an average of 10 weeks
Validation and reproducibility testing for MRI
body composition analysis
Measured: through study completion, an average of 10 weeks
Validation and reproducibility testing for MRS
body composition analysis
Measured: through study completion, an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start8 May 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bettina Mittendorfer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bettina Mittendorfer, University of Missouri-Columbia
- Investigators
- Bettina Mittendorfer, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286761
- Sponsor's protocol ID
- 2100332
- Acronym
- VAL
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research
- ClinicalTrials.gov ID
- NCT06286761
- Acronym / sponsor ID
- VAL / 2100332
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bettina MittendorferUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: endothelial cell collectionFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- convenience population of volunteers in mid-Missouri region
Key inclusion criteria (11 listed)
- ≥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
Key exclusion criteria (12 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endothelial cell collectionAlso: MRI, DEXA, MRS, blood testingParticipants 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 | Single arm |
Primary outcome
Validation and reproducibility testing for blood assays
Time frame: 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 endothelial cell collection
Time frame: through study completion, an average of 10 weeks
endothelial cell quantity collected
Validation and reproducibility testing for mixed meal ingestion
Time frame: through study completion, an average of 10 weeks
tolerability and palatability of meal type (protein concentration, carbohydrate concentration)
Validation and reproducibility testing for glucose tolerance testing
Time frame: through study completion, an average of 10 weeks
glucose levels
Validation and reproducibility testing for DEXA
Time frame: through study completion, an average of 10 weeks
body composition analysis
Validation and reproducibility testing for MRI
Time frame: through study completion, an average of 10 weeks
body composition analysis
Validation and reproducibility testing for MRS
Time frame: through study completion, an average of 10 weeks
body composition analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vasavi Shabrish, PhD contact
Bettina Mittendorfer, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Bettina Mittendorfer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather McHatton, MPH, RN ((573) 882-7619, heathermchatton@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation and reproducibility testing for blood assays (time frame: through study completion, an average of 10 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.