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Набор по приглашению NCT03585153

Multicenter Assessment of the Pancreas in Type 1 Diabetes

— Наблюдательное Diabetes Mellitus

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: Non-contrast magnetic resonance imaging.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus. Базовые параметры: от 8 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, Австралия
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 overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative magnetic resonance imaging (MRI) approaches.

Подробное описание

This research applies magnetic resonance imaging (MRI) techniques to study the pancreas of individuals with type 1 diabetes (T1D) and other forms of diabetes. Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults, and in non-diabetic individuals expressing islet autoantibodies that portend the development of T1D. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. These unexpected findings raise fundamental questions that challenge our understanding of T1D pathogenesis. These changes in pancreatic volume and size before and soon after onset of T1D, as detected by MRI, appear to be a marker of the T1D pathogenic disease process. There is an urgent need to determine whether similar observations can be obtained at different centers using different MRI platforms. Discovery of unknown changes may lead to new ways to treat disease. The MRI techniques may also be useful for following how T1D is progressing in different people, determining whether new drugs are effective, and ultimately detecting T1D in people earlier than currently possible.

Вмешательства

  • Другое Non-contrast magnetic resonance imaging
    subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

Первичные конечные точки

  • Pancreas Volume Index [Срок оценки: up to 10 years]
Вторичные конечные точки (1)
  • MRI of pancreas - Apparent Diffusion Coefficient [Срок оценки: up to 10 years]

Критерии участия

Критерии включения

  • Subjects at least 8 years of age
  • Subjects with T1D must be imaged within 100 days of their date of diagnosis
  • Subjects must be able to read and provide assent/informed written consent

Критерии исключения

  • Subjects with pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumors
  • Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means because such devices may be displaced or malfunction
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
  • Subjects who are pregnant or breast-feeding. Urine pregnancy test will be performed on women of child bearing potential who are not practicing appropriate contraception measures or menstruating.
  • Subjects who exhibit significant anxiety and/or claustrophobia
  • Subjects incapable of giving assent/informed written consent
  • For controls: subjects who have first degree relatives with T1D

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 · 4 центра
  • University of Colorado, Barbara Davis Center — Aurora
  • University of Chicago, Kovler Diabetes Center — Chicago
  • Vanderbilt University Medical Center — Nashville
  • University of Texas at Austin, Dell Medical School — Austin
Австралия · 1 центр
  • St. Vincent's Institute of Medical Research — Melbourne

Публикации

  • Virostko J, Williams J, Hilmes M, Bowman C, Wright JJ, Du L, Kang H, Russell WE, Powers AC, Moore DJ. Pancreas Volume Declines During the First Year After Diagnosis of Type 1 Diabetes and Exhibits Altered Diffusion at Disease Onset. Diabetes Care. 2019 Feb;42(2):248-257. doi: 10.2337/dc18-1507. Epub 2018 Dec 14. PMID 30552135
  • Williams JM, Hilmes MA, Archer B, Dulaney A, Du L, Kang H, Russell WE, Powers AC, Moore DJ, Virostko J. Repeatability and Reproducibility of Pancreas Volume Measurements Using MRI. Sci Rep. 2020 Mar 16;10(1):4767. doi: 10.1038/s41598-020-61759-9. PMID 32179809
  • Wright JJ, Dulaney A, Williams JM, Hilmes MA, Du L, Kang H, Powers AC, Moore DJ, Virostko J. Longitudinal MRI Shows Progressive Decline in Pancreas Size and Altered Pancreas Shape in Type 1 Diabetes. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2699-2707. doi: 10.1210/clinem/dgad150. PMID 36938587

Идентификаторы

NCT: NCT03585153 · 130883 · 3-SRA-2019-759-M-B · 3-SRA-2015-102-M-B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗