Investigating Markers of Energy Metabolism in the CNS and Periphery in Pregnant Women With Varying Degrees of Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Insulin Level (mg/dl)
研究概览
简要总结
The investigators seek to examine the metabolic changes that occur amongst obese and lean pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant age matched controls. Given the adaptive tendency of the maternal body to use alternative energy sources such as ketones and free fatty acids rather than glucose and to shunt glucose and amino acids to the fetus, the investigators hypothesize that the amino acid and fatty acid profile will be reflective of this adaptive change and that maternal insulin resistance will result in alterations in this pattern in both the plasma and CSF. Furthermore, the investigators also hypothesize that maternal degrees of insulin resistance will also be reflected in CSF hormonal changes.
详细描述
We seek to investigate for the first time whether CSF branched chain amino acid, free fatty acid, and energy regulatory hormone levels are altered in comparison to plasma levels among pregnant and non-pregnant individuals with varying degrees of insulin resistance. Furthermore, we seek to understand the effects of pregnancy on central and peripheral energy metabolism using metabolomic profiling as well as traditional hormonal measurements in maternal blood, urine, cerebrospinal fluid as well as cord blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Pregnant women ages 18-45, pre-pregnancy BMI 18-30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
- •Pregnant women ages 18-45, pre-pregnancy BMI >30 with normal glycemic control scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
- •Pregnant women ages 18-45 with diabetes (gestational or pre-existing type 2 DM) scheduled for an elective cesarean delivery at Yale-New Haven Hospital on the Labor and Birth unit
- •Non-pregnant, non-diabetic women age 18-45 scheduled for lumbar puncture at the Yale-New Haven Hospital Lumbar puncture clinic
- •Able to read and understand English at 6th grade level or higher
排除标准
- •Medical disorders other than diabetes. Including psychiatric disorders, alcohol abuse, HIV, hepatitis, renal, hepatic disease, heart disease, active systemic infection, malignancy
- •Pregnancy related medical problems including preeclampsia
- •Major congenital fetal anomalies
- •Smoking and illicit drugs (marijuana, cocaine, benzodiazepines, barbituates)
- •Use of weight loss supplements or dieting 6 months prior to study.
- •Corticosteroid use within 6 months of study.
- •Uncontrolled thyroid disease
- •Medications other than multivitamin, folic acid, or diabetic medications.
结局指标
主要结局
Insulin Level (mg/dl)
时间窗: Baseline (At the time of surgery)
Blood Glucose Level (mmol/L)
时间窗: Baseline (At the time of surgery)
Plasma Leptin Level
时间窗: Baseline (At the time of surgery)
次要结局
未报告次要终点