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临床试验/NCT03504319
NCT03504319已完成不适用

The Role of Physical Activity During Pregnancy on Metabolic Function, Inflammation, and Maternal and Neonatal Outcomes

Western Kentucky University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Change in metabolic inflexibility

研究概览

简要总结

Maternal obesity during pregnancy is a serious public health concern as it contributes to inflammation, insulin resistance, and excessive gestational weight gain- all of which negatively impact maternal and neonatal health. Fortunately, physical activity during pregnancy improves obstetric and infant outcomes associated with obesity. Specifically, data from our group demonstrated that irrespective of body weight, women who were physically-active during pregnancy had lower levels of systemic inflammation; however, the mechanism/s driving these changes are poorly understood. Previous studies in non-gravid populations suggest obesity-associated overnutrition may contribute to inflammation and this subsequent inflammation may lead to further metabolic dysfunction- perpetuating a vicious cycle. However, the connections between physical activity, inflammation, and metabolic dysfunction (i.e. metabolic inflexibility), particularly in response to a high-fat meal (similar to that which is typically consumed in a Western diet), among lean and obese pregnant women have not been studied. Thus, this study will examine the impact of a physically-active lifestyle on inflammatory and metabolic responses to a high-fat meal in lean and obese pregnant women. Understanding mechanisms connecting maternal physical activity to improved outcomes will better inform future targeted intervention strategies. The goal of this study is to determine the role of a physically-active lifestyle during pregnancy on metabolic function and inflammation following a high-fat meal in lean and obese pregnant women.

详细描述

Maternal obesity is a significant public health concern in the United States as one in three women enter pregnancy obese, and maternal obesity is associated with a large number of unfavorable maternal and neonatal outcomes. Fortunately, a physically active lifestyle during pregnancy has been shown to improve unfavorable outcomes often associated with obesity. Physical activity during pregnancy has been shown to improve maternal insulin resistance and reduce maternal gestational weight gain. In addition, neonates of physically active women have lower adiposity compared to neonates born to inactive women. Although the relationships between physical activity and maternal and neonatal outcomes are well-established, little is known about the potential for metabolic dysfunction and/or inflammation to serve as mechanisms mediating the positive impact of physical inactivity on maternal and neonatal health. Understanding mechanisms connecting maternal physical activity to improved outcomes will better inform future targeted intervention strategies.

Metabolic adaptations, specifically changes in lipid and carbohydrate metabolism, occur during normal physiologic pregnancy to provide an adequate nutrient supply to the developing fetus despite intermittent maternal dietary intake. However, in obese pregnant women these metabolic adaptations may be augmented by additional maternal metabolic dysfunction. Further, it is well-established that metabolic dysfunction in obese pregnant women has serious implications for maternal and neonatal health. Maternal substrate metabolism not only contributes to maternal health conditions such as gestational diabetes, but it also plays a major role in fetal growth and development. The "fetal origins hypothesis" suggests that an altered intrauterine metabolic environment may contribute to the programming of short and long-term neonatal outcomes.

Metabolic inflexibility may play a major role in maternal and neonatal health; however, it has not been studied during pregnancy. In non-gravid populations, physical activity is positively correlated with metabolic flexibility, and physical activity improves metabolic flexibility in lean and obese individuals.

The role of physical activity in modulating metabolic inflexibility in lean and obese pregnant women has not been studied. However, an impaired ability to switch to fat metabolism after a high-fat load is likely a better indicator of metabolic dysregulation than metabolism during resting conditions. Therefore, the current study proposes to look at the role of a physically active lifestyle on metabolic function in lean and obese pregnant women.

This project will also determine the relationships between inflammation, metabolic flexibility, and other important maternal (gestational weight gain) and neonatal (adiposity and insulin resistance) outcomes.The goal of this project is to investigate the impact of a physically-active lifestyle on inflammatory and metabolic responses to a high-fat meal in lean and obese pregnant women.

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-44
  • Confirmed singleton viable pregnancy with no fetal abnormalities at routine 18-22 ultrasonography
  • Receipt of prenatal care and plans to deliver at The Medical Center in Bowling Green, KY
  • Completion of a normal routine, standard of care gestational diabetes screen
  • Physician release to participate in the study procedures

排除标准

  • Multiple gestation pregnancy
  • Inability to provide voluntary informed consent
  • Current use of illegal drugs (cocaine, methamphetamine, opiates, etc...)
  • Current smoker who does not consent to cessation
  • Current usage of daily medications by class: corticosteroids, anti-psychotics (known to alter insulin resistance and metabolic profiles)
  • History of gestational diabetes, pre-pregnancy diabetes or prior macrosomic (>4500g) infant (each elevate the risk for gestational diabetes in the current pregnancy, or undiagnosed gestational diabetes)
  • Dietary restrictions prohibiting them from consuming the standardized meal/high-fat load

结局指标

主要结局

Change in metabolic inflexibility

时间窗: Metabolic inflexibility will be assessed 2 and 4 hours after shake consumption

The increase in fat metabolism after smoothie consumption (lipid oxidation in g/min after shake minus lipid oxidation (g/min) before shake/ lipid oxidation before shake (g/min))

次要结局

  • Neonatal insulin(At delivery)
  • Change in maternal insulin resistance(At baseline, 2 hours, and 4 hours post shake consumption)
  • Change in inflammation(Inflammatory markers will be assessed at baseline, 2 hours, and 4 hours post smoothie consumption)
  • Neonatal adiposity(24-48 hours post delivery)
  • Maternal gestational weight gain(Maternal weight at delivery will be obtained from her last reported weight before delivery, pre-pregnancy weight will be determined from self-report at study enrollment (~28 weeks))
  • Neonatal insulin resistance(At delivery)
  • Change in maternal glucose(At baseline, 2 hours, and 4 hours post shake consumption)
  • Neonatal glucose(At delivery)
  • Change in maternal insulin(At baseline, 2 hours, and 4 hours post shake consumption)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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