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临床试验/NCT03585153
NCT03585153Enrolling By Invitation不适用

Multicenter Assessment of the Pancreas in Type 1 Diabetes

Vanderbilt University Medical Center5 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2014年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
250
试验地点
5
主要终点
Pancreas Volume Index

研究概览

简要总结

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.

详细描述

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.

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
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Pancreas Volume Index

时间窗: up to 10 years

Size of the pancreas determined by longitudinal MRI, normalized to subject weight

次要结局

  • MRI of pancreas - Apparent Diffusion Coefficient(up to 10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Moore

Professor of Medicine

Vanderbilt University Medical Center

研究点 (5)

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