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临床试验/NCT03412981
NCT03412981已完成不适用

Obesity and Adipose Tissue Inflammation in Pregnant Mothers

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年12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
27
试验地点
2
主要终点
TNFa

研究概览

简要总结

To date very little research has been conducted on pregnant mothers. Research shows that mothers with obesity and gestational diabetes have children who have a higher risk of later developing obesity and diabetes compared to children born to non-obese mothers but the mechanisms are not known. The maternal environment may place these babies at greater risk and it is possible that fat tissue (adipose tissue) releases many chemicals (adipokines and inflammatory cytokines) which may have an impact on the baby. Mothers who have greater amounts of adipose tissue most likely release these adipokines into the baby and it may affect the baby's body composition and/or health.

This project will establish if there is a relationship between obesity and adipose tissue inflammation in pregnant mothers, and if there is a link between inflammation and the child's body composition.

We will recruit mothers with low risk pregnancies already schedule for a C section at about 36 wk. We will do initial testing at 36 wk, adipose tissue collection at delivery, and conduct post testing at 1 month postpartum on the mother and the baby.

详细描述

Study 1 Visit 1: Sign consent form, age, height, weight, and completion of questionnaires (e.g. food record). Consent will allow the investigators to gain access to medical record to record pregnancy-related health information on the mother (e.g., prenatal care including but not limited to maternal vital signs, clinical documents and fetal well-being - such as # pregnancies; reason for scheduled C-section; starting body weight and weight gain during pregnancy; BP throughout pregnancy; glucose challenge test (GCT) and glucose tolerance test (GTT) results; disease history; medications; pregnancy complications). The investigators will also access any fetal monitoring (e.g., including any cardiac ultrasounds that may have been performed.) Screening fasting bloods - glucose, insulin, HbA1c, blood lipids, CRP, inflammatory cytokine panel (TNFa, IL-6, IL-4, IL-13), adipokines (adiponectin, leptin), and sex hormones (e.g., estradiol, testosterone, progesterone). The investigators will also perform a limited ultrasound to assess fetal cardiac function and adiposity at this time. Subjects will be given a physical activity monitor to wear for 7 days.

Visit 2: C-section: At this visit during the C-section, a sample (~1000 mg/depot) of omental and subcutaneous fat samples will be taken for assessment of inflammatory genes/proteins. Cord blood (~15 ml) for assessment of inflammatory genes/proteins.

Visit 3: 1 month post-partum Mother: Resting blood pressure, fasting blood sample (glucose, insulin, HbA1c, blood lipids, CRP, inflammatory cytokine panel (TNFa, IL-6, IL-4, IL-13), adipokines (adiponectin, leptin)), sex hormones (estradiol, progesterone, testosterone), and body composition measurement. Completion of questionnaires. Subjects will be given a physical activity monitor to wear for 7 days.

Study 2 Women will only be recruited to complete the C-section as described above They will have the option to have the baby measured in the pea pod and to wear a physical activity monitor for a week in the month before delivery.

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
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers who have low risk pregnancies (21-40 years) and are already scheduled to have a C-section. BMI ≤ 40 kg/m2

排除标准

  • We will exclude emergency C-sections
  • Subjects will have had a screening ultrasound that demonstrated the absence of congenital anomalies as part of routine prenatal care
  • Mothers with high risk pregnancy
  • BMI > 40 kg/m2

结局指标

主要结局

TNFa

时间窗: at delivery

TNFa, IL-6, IL-4, IL-13

次要结局

  • IL-4(at delivery)
  • IL-13(at delivery)
  • IL-6(at delivery)
  • body fat(after delivery)
  • baby weight(at birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Kanaley

professor

University of Missouri-Columbia

研究点 (2)

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