Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Validation and reproducibility testing for endothelial cell collection
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 and ≤100 years of age
- •body mass index ≥16.0 and ≤60 kg/m2
排除标准
- •<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.
结局指标
主要结局
Validation and reproducibility testing for endothelial cell collection
时间窗: through study completion, up to 6 months
endothelial cell quantity collected
Validation and reproducibility testing for DEXA
时间窗: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility testing for MRI
时间窗: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility testing for MRS
时间窗: through study completion, up to 6 months
body composition analysis (percentage fat and muscle)
Validation and reproducibility of vascular (endothelial) function test
时间窗: through study completion, up to 6 months
non-invasive vascular function test (measured using EndoPat machine)
Validation and reproducibility of adipose (fat) tissue biopsy
时间窗: through study completion, up to 6 months
microscopic characteristics of tissue collected
Validation and reproducibility testing of muscle tissue biopsies
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Validation and reproducibility testing for mixed meal ingestion
时间窗: through study completion, up to 6 months
palatability of meal type (protein concentration, carbohydrate concentration) as measured by amount of meal consumed
Validation and reproducibility testing for glucose tolerance testing
时间窗: through study completion, up to 6 months
glucose levels (mg/dL) at various time points including fasting, random, and postprandial
Evaluation of the validity and reproducibility of insulin results in the laboratory environment
时间窗: 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
Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment
时间窗: 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
Evaluation of the validity and reproducibility of glucose results in the laboratory environment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Bettina Mittendorfer
Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit
University of Missouri-Columbia