此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Islet Function in Gestational Diabetes

2026年9月4日 更新者：Aoife Egan、Mayo Clinic
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

90

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
        • 接触：
          • Jeanette Laugen
          • 电话号码：507-255-8110
        • 接触：
          • Amy Zipse
          • 电话号码：507-255-9278

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Pregnant individuals with a viable singleton pregnancy who have completed second trimester gestational diabetes screening and are eligible for classification as either gestational diabetes mellitus or no gestational diabetes mellitus.
  • Participants must be willing and able to provide informed consent and complete planned pregnancy and postpartum study visits.

Exclusion Criteria:

  • Active systemic illness (e.g. chronic kidney disease, hypertension)
  • Pre-pregnancy diabetes mellitus
  • Multiple gestation, major fetal anomaly, or non-viable pregnancy on ultrasound
  • Fasting glucose ≥ 100 mg/dL or HbA1c ≥ 5.7% in early pregnancy
  • One abnormal value on the 3-hour 100 g oral glucose tolerance test
  • Glucose at least 190 mg/dL on glucose challenge testing without subsequent 3-hour oral glucose tolerance testing
  • Use of medication affecting glucose metabolism before pregnancy or in early pregnancy
  • Use of glucose-lowering medication (e.g. metformin, glyburide) other than insulin to treat gestational diabetes mellitus in the current pregnancy
  • History of upper gastrointestinal surgery that alters gastric emptying (e.g. bariatric surgery)
  • Hemoglobin < than 11 g/dL

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Women With Gestational Diabetes Mellitus
Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits.
药品：Exendin 9-39
Exendin 9-39 will be administered during one postpartum study day as an intravenous infusion at 300 pmol/kg/min for 4 hours, beginning 60 minutes before the graded glucose infusion and continuing through the end of the 180-minute glucose infusion study period
实验性的：Women Without Gestational Diabetes Mellitus
Pregnant participants without gestational diabetes mellitus, matched to the gestational diabetes group by parity, age, ethnicity, gestational week at diagnosis comparator timepoint, and first trimester body mass index.
药品：Exendin 9-39
Exendin 9-39 will be administered during one postpartum study day as an intravenous infusion at 300 pmol/kg/min for 4 hours, beginning 60 minutes before the graded glucose infusion and continuing through the end of the 180-minute glucose infusion study period

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
G50
大体时间：During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
The change in glucose concentration necessary to suppress glucagon secretion rate by 50%. A measurement of α-cell function.
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

次要结果测量

结果测量
措施说明
大体时间
Glucagon Secretion Rate
大体时间：During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
The amount of glucagon produced over time expressed as pmol/min. A measurement of α-cell function.
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
delta insulin secretion rate/delta glucose
大体时间：During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
This measurement quantifies the change in insulin secretion in response to rising glucose concentrations. it is a surrogate of β-cell function. Insulin secretion rate will be calculated from C-peptide concentrations using nonparametric deconvolution and population-based measures of C-peptide kinetics.
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
β-Cell responsivity (Φ)
大体时间：During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.
This index quantifies the relationship between fasting glucose and fasting insulin secretion rate. This will allow us to assess and quantify fasting β-cell function.
During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mayo Clinic

合作者

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

调查人员

  • 首席研究员：Aoife Egan, MB, BCh, PhD、Mayo Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2030年3月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月4日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 26-007703
  • 1R01DK148528-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅