Obesity and Obesity-related Medical ConditionsVALDNCT07083557
Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
An observational study of Obesity and Obesity-related Medical Conditions and Diabetes, 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, nutrition, and metabolism (the process by which a substance is… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Diabetes, Atherosclerotic Disease
- 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
- 1 Jan 2027to 1 Jul 2030
- 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 100 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 ≤100 years of age
- body mass index ≥16.0 and ≤60 kg/m2
Who cannot join
- <18 and >100 years of age
- body mass index <16.0 or >60 kg/m2
- allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians
- use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay/techniques being evaluated
- engaged in regular structured exercise >150 min per week unless needed for validation of the assay/technique being evaluated
- significant organ system dysfunction or diseases, except those that are sought for validation of the assay/technique being evaluated
- alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay/technique being evaluated
- pregnant women, persons who smoke, prisoners, and 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.
United States1 site, 1 recruiting
- Recruiting
University of Missouri-Columbia
Columbia, Missouri, 65211
Study coordinator, 573-884-6852, ahmc4@health.missouri.edu
About this study
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, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses 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 the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.
- Conditions
- Obesity and Obesity-related Medical Conditions, Diabetes, Atherosclerotic Disease, Heart Failure, MASH, Sarcopenia
- Being tested
- Endothelial cell collection
- Medical subject headings
- Obesity, Diabetes Mellitus, Heart Failure, Sarcopenia, Osteoporosis, Hyperparathyroidism, Hypoparathyroidism, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial cell collectionOther
Participants may opt to have testing performed including blood sampling, urine sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS, having adipose (fat) or muscle biopsies, or non-invasive endothelial function testing 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the validity and reproducibility of insulin results in the laboratory environment
Comparison of insulin results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Validation and reproducibility testing for endothelial cell collection
endothelial cell quantity collected
Measured: through study completion, up to 6 months
Validation and reproducibility testing for mixed meal ingestion
palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment
Comparison of urinalysis results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Validation and reproducibility testing for glucose tolerance testing
glucose levels (mg/dL) at various time points including fasting, random, and postprandial
Measured: through study completion, up to 6 months
Validation and reproducibility testing for DEXA
body composition analysis (percentage fat and muscle)
Measured: through study completion, up to 6 months
Validation and reproducibility testing for MRI
body composition analysis (percentage fat and muscle)
Measured: through study completion, up to 6 months
Validation and reproducibility testing for MRS
body composition analysis (percentage fat and muscle)
Measured: through study completion, up to 6 months
Validation and reproducibility of vascular (endothelial) function test
non-invasive vascular function test (measured using EndoPat machine)
Measured: through study completion, up to 6 months
Validation and reproducibility of adipose (fat) tissue biopsy
microscopic characteristics of tissue collected
Measured: through study completion, up to 6 months
Validation and reproducibility testing of muscle tissue biopsies
microscopic characteristics of tissue collected
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of C-peptide results in the laboratory environment
Comparison of C-peptide results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of glucagon results in the laboratory environment
Comparison of glucagon results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of free fatty acid level results in the laboratory environment
Comparison of free fatty acid level results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of glucose results in the laboratory environment
Comparison of glucose results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of ketone body results in the laboratory environment
Comparison of ketone body results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of cytokine results in the laboratory environment
Comparison of cytokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of adipokine results in the laboratory environment
Comparison of adipokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of lipid profile results in the laboratory environment
Comparison of lipid profile results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urine calcium results in the laboratory environment
Comparison of urine calcium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urine magnesium results in the laboratory environment
Comparison of urine magnesium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urine phosphorous results in the laboratory environment
Comparison of urine phosphorous results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urine sodium results in the laboratory environment
Comparison of urine sodium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urine oxalate results in the laboratory environment
Comparison of urine oxalate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Evaluation of the validity and reproducibility of urine citrate results in the laboratory environment
Comparison of urine citrate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies 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
- NCT07083557
- Sponsor's protocol ID
- 2127348
- Acronym
- VALD
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- 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 7 May 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 Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
- ClinicalTrials.gov ID
- NCT07083557
- Acronym / sponsor ID
- VALD / 2127348
- Conditions
- Obesity and Obesity-related Medical Conditions, Diabetes, Atherosclerotic Disease, Heart Failure, MASH, Sarcopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bettina MittendorferUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 24 Jul 2025 (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, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses 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 the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- convenience population of volunteers in mid-Missouri region
Key inclusion criteria (2 listed)
- ≥18 and ≤100 years of age
- body mass index ≥16.0 and ≤60 kg/m2
Key exclusion criteria (8 listed)
- <18 and >100 years of age
- body mass index <16.0 or >60 kg/m2
- allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians
- use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay/techniques being evaluated
- engaged in regular structured exercise >150 min per week unless needed for validation of the assay/technique being evaluated
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 collectionParticipants may opt to have testing performed including blood sampling, urine sampling, intravenous catheter placement with endothelial cell collection, oral glucose tolerance test, consuming a test meal, having imaging performed such as MRI, DEXA, MRS, having adipose (fat) or muscle biopsies, or non-invasive endothelial function testing 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 | – |
Primary outcome
Evaluation of the validity and reproducibility of insulin results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of insulin results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Validation and reproducibility testing for endothelial cell collection
Time frame: through study completion, up to 6 months
endothelial cell quantity collected
Validation and reproducibility testing for mixed meal ingestion
Time frame: through study completion, up to 6 months
palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed
Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urinalysis results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Validation and reproducibility testing for glucose tolerance testing
Time frame: through study completion, up to 6 months
glucose levels (mg/dL) at various time points including fasting, random, and postprandial
Validation and reproducibility testing for DEXA
Time frame: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility testing for MRI
Time frame: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility testing for MRS
Time frame: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility of vascular (endothelial) function test
Time frame: through study completion, up to 6 months
non-invasive vascular function test (measured using EndoPat machine)
Validation and reproducibility of adipose (fat) tissue biopsy
Time frame: through study completion, up to 6 months
microscopic characteristics of tissue collected
Validation and reproducibility testing of muscle tissue biopsies
Time frame: through study completion, up to 6 months
microscopic characteristics of tissue collected
Evaluation of the validity and reproducibility of C-peptide results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of C-peptide results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of glucagon results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of glucagon results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of free fatty acid level results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of free fatty acid level results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of glucose results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of glucose results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of ketone body results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of ketone body results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of cytokine results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of cytokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of adipokine results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of adipokine results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of lipid profile results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of lipid profile results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine calcium results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine calcium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine magnesium results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine magnesium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine phosphorous results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine phosphorous results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine sodium results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine sodium results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine oxalate results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine oxalate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
Evaluation of the validity and reproducibility of urine citrate results in the laboratory environment
Time frame: through study completion, up to 6 months
Comparison of urine citrate results across assays (methods of measuring) to evaluate the validity and reproducibility in the basic science laboratory environment across healthy and disordered populations
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 7 May 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.
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 and Obesity-related Medical Conditions and Diabetes, 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 2 inclusion and 8 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 7 May 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 Study coordinator (573-884-6852, ahmc4@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the validity and reproducibility of insulin results in the laboratory environment (time frame: through study completion, up to 6 months). The study lists 25 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 7 May 2026.