Islet Function in Gestational Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- G50
研究概览
简要总结
The purpose of this research is to understand how the function of the human pancreas changes during and after pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exendin 9-39 (Drug)
Women With Gestational Diabetes Mellitus
Pregnant participants diagnosed with gestational diabetes mellitus who complete pregnancy and postpartum metabolic study visits.
干预措施: Exendin 9-39 (Drug)
结局指标
主要结局
G50
时间窗: 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.
次要结局
- Glucagon Secretion Rate(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(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)(During pregnancy at approximately 26 to 32 weeks gestation and during the postpartum period at approximately 6 weeks to 3 months after delivery.)