A Pilot Study Evaluating the Use of a Novel Noninvasive Breath Test to Identify Patients at Risk for Developing Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The aim of our study is to evaluate the feasibility of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
研究概览
简要总结
The aim of our study is to evaluate the feasibility, and diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
详细描述
This prospective observational pilot study will include pregnant patients with a singleton fetus up to 33 weeks gestation.
Patients meeting the inclusion criteria who are willing to participate will be asked to drink 50 or 100 grams of glucose in 200 ml water (disposable plastic cup). The test will start at approximately 08:00 with no change in normal diet is needed prior to the GCT, or after an 8-14 hour overnight fast for the OGTT.
The test will be performed at the Maternal Fetal Medicine outpatient clinics, the Maternal Fetal Medicine unit for inpatients or at the patient's residence.
Samples collection
Glucose samples:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
- •ages 18 to 45 years old
- •A singleton pregnancy
- •Confirmed gestational age by a documented first-trimester ultrasound.
排除标准
- •Patients below the age of 18 or above 45 years-old
- •Patients diagnosed with gestational or pre-gestational diabetes
- •Patients with multiple pregnancies or fetuses with congenital and/or chromosomal anomalies
- •Patients after a multifetal pregnancy reduction (spontaneous or iatrogenic)
- •Patients not having a sonographic dating during the first trimester of pregnancy
- •Patients with conditions or medications that affect glucose metabolism
- •Patients who will refuse to consent, or are not fit or able to read, understand, or sign an informed consent.
结局指标
主要结局
The aim of our study is to evaluate the feasibility of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
时间窗: At the time of the glucose tolerance test (GCT/ OGTT)
We will assess feasibility via recruitment and test completion.
To evaluate the diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
时间窗: At the time of the glucose tolerance test (GCT/ OGTT)
We will assess agreement between exogenous glucose oxidation (breath test) and blood glucose (OGTT).
次要结局
未报告次要终点
研究者
Maya Oberman
Attending physician
Kaplan Medical Center