Clinical trial

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)

Recruiting now · Not applicable · 1 countries · Registry ID NCT07083557

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 100 Years

SexAll

Healthy volunteersAccepted

ConditionObesity and Obesity-related Medical Conditions, Diabetes, Atherosclerotic Disease, Heart Failure, MASH, Sarcopenia, Osteoporosis, Hyperparathyroidism, Hypoparathyroidism, Ischemic Heart Disease, Cystic Fibrosis (CF), Chronic Kidney Disease(CKD), Osteopenia, Cachexia

Full registry criteria

Inclusion Criteria: * ≥18 and ≤100 years of age * body mass index ≥16.0 and ≤60 kg/m2 Exclusion Criteria: * \<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.

Treatments and study arms

Endothelial cell collection

Other

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.

Primary outcomes

Evaluation of the validity and reproducibility of insulin results in the laboratory environmentthrough 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 collectionthrough study completion, up to 6 months

endothelial cell quantity collected

Validation and reproducibility testing for mixed meal ingestionthrough 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 environmentthrough 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 testingthrough study completion, up to 6 months

glucose levels (mg/dL) at various time points including fasting, random, and postprandial

Validation and reproducibility testing for DEXAthrough study completion, up to 6 months

body composition analysis (percentage fat and muscle)

Validation and reproducibility testing for MRIthrough study completion, up to 6 months

body composition analysis (percentage fat and muscle)

Validation and reproducibility testing for MRSthrough study completion, up to 6 months

body composition analysis (percentage fat and muscle)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Missouri-Columbia🇺🇸 Columbia, Missouri, United States

Open map

Study coordinatorContact

Email · Call 573-884-6852