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Идёт набор NCT07083557

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

— Наблюдательное Obesity and Obesity-related Medical Conditions Diabetes Atherosclerotic Disease Heart Failure

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 and Obesity-related Medical Conditions, Diabetes, Atherosclerotic Disease, Heart Failure. Базовые параметры: 18 лет — 100 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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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, 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.

Вмешательства

  • Другое Endothelial cell collection
    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 r

Первичные конечные точки

  • Evaluation of the validity and reproducibility of insulin results in the laboratory environment [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility testing for endothelial cell collection [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility testing for mixed meal ingestion [Срок оценки: through study completion, up to 6 months]
  • Evaluation of the validity and reproducibility of urinalysis results in the laboratory environment [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility testing for glucose tolerance testing [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility testing for DEXA [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility testing for MRI [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility testing for MRS [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility of vascular (endothelial) function test [Срок оценки: through study completion, up to 6 months]
  • Validation and reproducibility of adipose (fat) tissue biopsy [Срок оценки: through study completion, up to 6 months]

Критерии участия

Критерии включения

  • ≥18 and ≤100 years of age
  • body mass index ≥16.0 and ≤60 kg/m2

Критерии исключения

  • <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.

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-Columbia — Columbia

Идентификаторы

NCT: NCT07083557 · 2127348

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗