NL-OMON48407撤回不适用
ano-MRI to visualize pancreatic inflammation in individuals with recent-onset type 1 diabetes - Nano-PRIDE
ucleaire geneeskunde en radiologie0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Inclusion criteria (Individuals with type 1 diabetes):
- •* Within 6 months of diagnosis with type 1 diabetes
- •* Auto-antibody positive, - Inclusion criteria (Control individuals):
- •* No evidence of impaired glucose tolerance (HbA1c < 42 mmol/mol (6%),
- •fasting glucose < 6.1 mmol/L), - Inclusion criteria (general):
- •* Age > 18 years
- •Signed informed consent
排除标准
- •- Contra-indication to MRI scanning, iron infusion or hypersensitivity to the
- •active substance or any of the excipients (like mentioned in the SPC).
- •- Known drug allergies or history of severe asthma, eczema or other ectopic
- •- Inability to lie still for at least 30 minutes or comply with imaging
- •- Hemochromatosis or liver disease defined as ALAT or ASAT level of more than
- •three times the upper limit of normal range
- •- Renal dysfunction defined as MDRD < 40 ml/min/1.73m^2
- •- Current pregnancy or the wish to become pregnant within 2 months
- •- Breast feeding
- •- Incapability to provide informed consent
- •- Pancreatitis
- •- Evidence of other inflammatory disease(s)
研究者
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