EUCTR2017-002959-29-NL进行中（未招募）1 期
Comparison of the beta cell mass during and shortly after the honeymoon phase of type 1 diabetes using Ga-68-exendin PET - GLP1-honeymoon
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •-Age =16 years
- •-Subject is diagnosed with type 1 diabetes (T1D)
- •-Presence of anti-GAD (glutamic acid decarboxylase)
- •- Subject is in the honeymoon phase of T1D: IDAA1c <9
- •-17= BMI =30 kg/m^2
- •-Ability to sign informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase lV
- •- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range
- •- Renal disease defined as MDRD <40 ml/min/1.73 m^2
- •- Pregnancy or the wish to become pregnant within 6 months after the study
- •- Breastfeeding
- •- BMI <17 kg/m^2 or BMI >30 kg/m^2
- •- Age <16 years
- •- When the end of the honeymoon phase (IDAA1c =9) is not observed within 11 to 13 months after the inclusion of the subject
- •- lnability to sign informed consent
研究者
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