Multicenter Assessment of the Pancreas in Type 1 Diabetes
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
- 是
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
Daniel Moore
Professor of Medicine
Vanderbilt University Medical Center
