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

Radboud university medical center0 个研究点目标入组 18 人开始时间: 2017年7月24日最近更新: 2021年6月28日

适应症

试验速览

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•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
•- T1D diagnosed =1 year at the start of the study
•- HbA1c >8.5 (>69 mmol/mol)
•- 17= BMI =30 kg/m^2
•- 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)
•- Ability to sign informed consent
•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 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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

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