Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research
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 (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.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥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
排除标准
- •<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.
结局指标
主要结局
Validation and reproducibility testing for endothelial cell collection
时间窗: through study completion, an average of 10 weeks
endothelial cell quantity collected
Validation and reproducibility testing for mixed meal ingestion
时间窗: through study completion, an average of 10 weeks
tolerability and palatability of meal type (protein concentration, carbohydrate concentration)
Validation and reproducibility testing for blood assays
时间窗: 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 glucose tolerance testing
时间窗: through study completion, an average of 10 weeks
glucose levels
Validation and reproducibility testing for DEXA
时间窗: through study completion, an average of 10 weeks
body composition analysis
Validation and reproducibility testing for MRS
时间窗: through study completion, an average of 10 weeks
body composition analysis
Validation and reproducibility testing for MRI
时间窗: through study completion, an average of 10 weeks
body composition analysis
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