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临床试验/NCT00634764
NCT00634764终止不适用

Resting Metabolic Rate, Insulin Resistance, and Attitude Towards Weight Gain During Pregnancy to Predict Maternal Weight Gain and Neonatal Body Composition.

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Maternal weight gain, resting metabolic rate (kcal/day)

研究概览

简要总结

Obesity is a significant health issue in the United States with 30% of the US population considered obese defined as a body mass index above 30 kg/m2. Obesity is associated with long term health complications including diabetes and cardiovascular disorders. During pregnancy, obesity is associated with an increased risk of fetal macrosomia and birth injury, as well as increased risk of gestational diabetes, preeclampsia, cesarean birth, and preterm birth. The intrauterine environment has been purported to influence the early childhood and lifelong risk of obesity and the metabolic syndrome (obesity, hyperlipidemia, and insulin resistance [IR]). The Institute of Medicine guidelines for maternal weight gain in pregnancy provide an estimate for population goals, but may be inadequate for individual patient needs. Other factors, such as the degree of maternal IR and resting metabolic rate (RMR) may be more predictive of actual nutritional needs during pregnancy. A better determination of caloric and exercise needs may allow the development of more specific dietary recommendations during pregnancy. Optimal nutrition will result in improved maternal and neonatal outcomes. As the intrauterine environment may have important impacts on neonatal and childhood metabolic and cardiovascular outcomes, creation of a favorable intrauterine environment through optimal maternal nutritional and exercise guidelines may reduce well documented problems such as fetal macrosomia, birth injury, cesarean delivery, and later predisposition toward childhood obesity.

The goal of this pilot trial therefore is to correlate maternal resting metabolic rate, dietary characteristics, and insulin resistance levels with fetal birth weight and body composition in an effort to determine which factors are associated with excessive fat mass in the neonate, placing them at increased lifetime risk of obesity.

We hypothesize that women with lower resting metabolic rates (RMR) in the first trimester will demonstrate a greater maternal weight gain, when adjusted for caloric intake and activity. It is also hypothesized that for a given RMR, the degree of maternal insulin resistance (IR) predicts birthweight adjusted for a given caloric intake. A third hypothesis is that women with increased insulin resistance (measured by HOMA) will result in neonates with larger birth weights and a greater degree of neonatal fat mass as measure by DEXA scan, adjusted for RMR and diet characteristics.

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

入选标准

  • Women must be obtaining prenatal care at Cannon Place clinic or at the Prenatal Wellness Center
  • Enrolled for prenatal care at less than 16 weeks gestational age
  • Singleton pregnancy without fetal abnormalities
  • Ability to provide informed consent
  • Subjects must complete prenatal visits when data will be collected, and be willing and able to attend three GCRC study visits
  • Maternal age >18 and <45
  • Neonate born to mother enrolled in trial

排除标准

  • Subjects with diabetes, hypertension, prior preterm birth, chronic respiratory disease (asthma on daily medication, COPD, cystic fibrosis) or maternal cardiac disease
  • Subjects currently taking insulin sensitizing medications (metformin)
  • Subject unable to perform MedGem procedure
  • Neonates delivered prior to 34 weeks gestational age will be excluded from analysis by the DEXA scan
  • Neonates with fetal anomalies diagnoses in the antenatal period or postpartum will not be included in the study

结局指标

主要结局

Maternal weight gain, resting metabolic rate (kcal/day)

时间窗: During gestation

Neonatal birth weight (gram), ponderal index

时间窗: After birth

次要结局

  • Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude(During gestation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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