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Идёт набор NCT06286761

Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)

— Наблюдательное Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: endothelial cell collection.
Кому может быть актуально
Состояния в реестре: Obesity. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Metabolism Research

Обзор

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.

Вмешательства

  • Другое endothelial cell collection
    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 vari

Первичные конечные точки

  • Validation and reproducibility testing for blood assays [Срок оценки: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for endothelial cell collection [Срок оценки: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for mixed meal ingestion [Срок оценки: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for glucose tolerance testing [Срок оценки: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for DEXA [Срок оценки: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for MRI [Срок оценки: through study completion, an average of 10 weeks]
  • Validation and reproducibility testing for MRS [Срок оценки: through study completion, an average of 10 weeks]

Критерии участия

Критерии включения

  • ≥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

Критерии исключения

  • <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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Missouri School of Medicine — Columbia

Идентификаторы

NCT: NCT06286761 · 2100332

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗