Validation of a Novel Screening Test for Maternal Insulin Resistance and Predicting Maternal Fetal Outcomes: A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gestational Diabetes
研究概览
简要总结
This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the results of this initial trial, investigators plan to perform a larger trial at UTMB.
Quantose IR is a fasting blood test for insulin resistance and prediabetes, and is clinically validated in non-pregnant individuals. The Quantose IR Score is based on three novel nonglycemic biomarkers, as well as insulin, and provides a comprehensive measure of insulin resistance. These analytes include:
- α-HB (α-hydroxybutyrate): positively correlated with insulin resistance and indicative of early β-cell dysfunction.
- L-GPC (linoleoyl-glycerophosphocholine): negatively correlated with insulin resistance and impaired glucose tolerance.
- Oleic Acid: positively correlated with increasing lipolysis and insulin resistance.
- Insulin: increased insulin is characteristic of insulin resistance and is an independent risk factor for type 2 diabetes and cardiovascular disease.
Quantose IGT is designed to estimate the risk of being IGT. It is calculated from a multiple logistic regression model based on the fasting plasma levels of:
- Glucose.
- α-HB.
- β-HB.
- 4-methyl-2-oxopentanoic acid.
- LGPC.
- Oleic acid.
- Serine.
- Vitamin B5. Participants in the study will be consenting to data collection and two visits for lab draw. The investigators will then evaluate the performance of the Quantose IR and Quantose IGT in the study population.
详细描述
This is a prospective cohort non-interventional study. Subjects will be identified during the time of a prenatal visit at one of the UTMB clinics. All necessary institutional and regulatory approval will be obtained prior to enrolling any candidates for this study.
Potential subjects that are not patients of the investigator or patients of the study team members, they will not be contacted by study staff unless they have been informed of the study by their medical provider and express an interest in receiving more information on the study or wish to enroll in the study. Under the direction of the PI, trained research staff will be available in the UTMB prenatal care clinics to screen and consent subjects according to study protocol. The Perinatal Research Division (PRD) has staff based in the UTMB Maternal Health (OB) clinics. These research staff members will screen the charts and electronic medical records of prenatal patients receiving care in the OB clinics. In order to contact potential study participants, the HIPAA waiver is submitted.
In addition, the OB clinic staff will be in serviced on the study and encouraged to refer potential subjects to the PRD staff. Other than the blood samples for this study, the management of pregnancy and delivery will be according to the standard of care at UTMB and will be up to the clinical provider.
Blood samples will be collected during 2 windows, early window (gestational age 10 0/7 to 13 6/7 weeks) and late window (gestational age 24 0/7 to 28 0/7 weeks) and stored at -800C in our perinatal research division. An aliquot will be sent to Metabolon to run the Quantose IR and Quantose IGT. The laboratory and the investigators will be blinded to the outcomes of the patient.
Testing using Quantose IR and Quantose IGT: The blood draws will be timed to coincide with clinically indicated blood tests as much as possible (e.g. first visit labs, aneuploidy screening, gestational diabetes screening).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older.
- •Singleton pregnancy.
- •Able to provide consent.
- •Gestational age 10 0/7 to 13 6/7 weeks.
- •Planned delivery at UTMB (John Sealy Hospital (JSH) or League City Hospital Campus.
- •Pre-pregnancy or early pregnancy BMI > or = 30 kg/m2
排除标准
- 未提供
结局指标
主要结局
Gestational Diabetes
时间窗: Up to 28 0/7 weeks of gestation
Development of gestational diabetes (based on the two step approach: 1hr glucose screen \> 135mg/dL and 2/4 abnormal values in a 3 hr OGTT using the Carpenter and Coustan
次要结局
- Insulin resistance(Up to 28 0/7 weeks of gestation)
- Fasting Plasma glucose(Up to 28 0/7 weeks of gestation)
- NICU admission(up to 7 days after delivery)
- Fasting Insulin(Up to 28 0/7 weeks of gestation)
- Neonatal hypoglycemia(up to 7 days after delivery)
- 1 hour glucola(Up to 28 0/7 weeks of gestation)
- Perinatal death(up to 7 days after delivery)