Beta cell imaging in type 1 diabetes with stable near-normal and unstable glucose control using PET - GLP1-reg

Radboud Universitair Medisch Centrum0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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.
•- Intact hypoglycemic awareness as assessed by a score of 0 or 1 on the
•modified Clarke*s questionnaire
•- Ability to sign informed consent
•T1D patients with unstable glucose control:
•- Age *18 years
•- T1D diagnosed *1 year at the start of the study
•- Ability to sign informed consent
•- Option 1: HbA1c *8.5 (*69 mmol/mol) and in addition a minimum of 2 severe
•hypoglycemic events in the past year, or an impaired awareness of hypoglycemia
•(IHA), as assessed by a score of 2 or more on the modified Clarke*s
•questionnaire (subjects may comply with both criteria, but this is not a
•requirement). Option 2: HbA1c *8.0 (*64 mmol/mol) and in addition a minimum of
•2 severe hypoglycemic events in the past year, or an impaired awareness of
•hypoglycemia (IHA), as assessed by a score of 3 or more on the modified
•Clarke*s questionnaire (subjects may comply with both criteria, but this is not
•a requirement)
•- 17* BMI *30 kg/m^2

•- Previous treatment (within 6 months) with synthetic Exendin (Exenatide,
•Byetta®) or Dipeptidyl-Peptidase IV inhibitors
•- Liver disease defined as aspartate aminotransferase or alanine
•aminotransferase level of more than three times the upper limit of normal range
•- Renal disease defined as MDRD <40 ml/min/1.73m^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
•- Inability to sign informed consent

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