EUCTR2010-023479-24-NL进行中（未招募）1 期
Effect of Interleukin-1 receptor antagonist on insulin sensitivity in subjects with type 1 diabetes mellitus. - Effect of IL-1RA on insulin sensitivity
Radboud University Nijmegen Medical Centre0 个研究点目标入组 16 人开始时间: 2010年11月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Type 1 diabetes with absence of residual Beta-cell function
- •Age 18-65 yrs
- •Body mass index of > 25 kg/m2
- •Insulin requirement > 0.5 U/kg bodyweight
- •HbA1c>7.5%, stable glycemic control
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inability to give informed consent
- •Presence of any medical condition that might interfere with the current study protocol.
- •Immunodeficiency or immunosuppressive treatment (including TNFa blocking agents and corticosteroids)
- •Anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs, 100 mg or less of aspirin per day is allowed)
- •Signs of current infection (fever, C-reactive protein (CRP) > 30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis.
- •A history of recurrent infections
- •Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women)
- •Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
- •Renal disease (creatinine > 130 µmol/l
- •Neutropenia < 2 x 109/l
研究者
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