2024-520392-27-00招募中2 期
Visualizing beta cells in patients with a history of gestational diabetes.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without a history of gestational diabetes by quantitative analysis of PET images.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Pregnancy with diagnosis of GDM, within the last 5 years
- •No other previous pregnancies
- •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)
- •Signed informed consent
排除标准
- •Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta@) or Dipeptidyl-Peptidase IV inhibitors
- •Breast feeding
- •Current pregnancy or the wish to become pregnant within 6 months
- •Renal dysfunction (Calculated creatinine clearance below 40 ml/min)
- •Liver disease defined as aspartate aminotransferase or alan¡ne aminotransferase level of more than three times the upper limit of normal range
- •Age < 18 years
- •incapacitated
- •no signed informed consent
结局指标
主要结局
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.
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.
次要结局
- The correlation between Ga-exendin tracer accumulation and beta cell function of the subjects
研究者
Sevilay Tokgöz
Scientific
Radboud universitair medisch centrum Stichting
研究点 (1)
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