EXENATIDE for Gestational diabetes

Inclusion criteria

• {"criterion_text":"- Pregnancy with diagnosis of GDM, within the last 5 years"}
• {"criterion_text":"- No other previous pregnancies"}
• {"criterion_text":"- Complete resolution of GDM after delivery (HbAlc in normal range, fasting glucose < 1OO mg/dl for at least I year in the absence of active pharmacologic therapy or ongoing procedures)"}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta@) or Dipeptidyl-Peptidase IV inhibitors"}
• {"criterion_text":"- Breast feeding"}
• {"criterion_text":"- Current pregnancy or the wish to become pregnant within 6 months"}
• {"criterion_text":"- Renal dysfunction (Calculated creatinine clearance below 40 ml/min)"}
• {"criterion_text":"- Liver disease defined as aspartate aminotransferase or alan¡ne aminotransferase level of more than three times the upper limit of normal range"}
• {"criterion_text":"- Age < 18 years"}
• {"criterion_text":"- incapacitated"}
• {"criterion_text":"- no signed informed consent"}

Primary endpoints

• {"endpoint_text":"- The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake women with and without a history of GDM by PET/CT.","definition_or_measurement_approach":"Quantitative assessment of 68Ga-NODAGA-exendin-4 tracer accumulation in the pancreas by PET/CT imaging (quantitative analysis of PET images)."}

Secondary endpoints

• {"endpoint_text":"- The correlation between Ga-exendin tracer accumulation and beta cell function of the subjects","definition_or_measurement_approach":"Correlation between tracer accumulation (PET imaging) and beta cell function as assessed by oral glucose tolerance testing (OGTT)."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-01-2025

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands