EUCTR2017-002739-40-NL
进行中(未招募)
1 期
Beta cell imaging in type 1 diabetes with stable near-normal and unstable glucose control using PET - GLP1-reg
适应症Type 1 diabetesMedDRA version: 20.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
相关药物Byetta
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Type 1 diabetes
- 发起方
- Radboud university medical center
- 入组人数
- 18
- 状态
- 进行中(未招募)
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •lnclusion criteria: T1D patients with stable near\-normal glucose control:
- •\- Age \=18 years
- •\- T1D diagnosed \=1 year at the start of the study
- •\- HbA1c \<7 (\<53 mmol/mol)
- •\- 17\= BMI \=30 kg/m^2
- •\- No severe hypoglycemic events in the past year and a maximum of 2 severe hypoglycemic events in their entire life.
- •\- lntact hypoglycemic awareness as assessed by a score of 0 or 1 on the modified Clarke's questionnaire
- •\- Ability to sign informed consent
- •lnclusion criteria: T1D patients with unstable glucose control:
- •\- Age \=18 years
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 \<18 years
- •\- lnability to sign informed consent
结局指标
主要结局
未指定
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