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临床试验/NCT05298735
NCT05298735已完成不适用

Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging

研究概览

简要总结

Approximately 400,000 people are living with type 1 diabetes mellitus (T1DM) in the United Kingdom: one of the highest rates in the world. It is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. It is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. Therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. Evaluation of novel therapies for T1DM requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. A new approach is manganese-enhanced magnetic resonance imaging (MEMRI). This proof-of-concept study was designed to investigate whether MEMRI can be used as a measure of beta-cell function in people with T1DM.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • No regular medications
  • No known significant medical conditions

排除标准

  • Inability to consent
  • Renal failure (eGFR <30 mL/min/1.73 m2)
  • Standard MRI contraindications
  • Pregnancy or breast feeding

结局指标

主要结局

Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging

时间窗: 30 minutes after contrast administration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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