The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome: the LITAPO Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change of biomarkers of preeclampsia
研究概览
简要总结
During pregnancy, hypertriglyceridemia is associated with adverse pregnancy outcomes, including gestational hypertension, preeclampsia, gestational diabetes mellitus, large for gestational age (LGA), and preterm delivery. However, whether lifestyle intervention for hypertriglyceridemia during pregnancy improves pregnancy outcomes remains unknown. Therefore, we will conduct a randomized controlled trial to investigate this issue.
At a tertiary medical center, we will enroll 70 pregnant women in this prospective, open-label, randomized controlled, pilot study comparing the effect of lifestyle intervention for hypertriglyceridemia versus control between Mar 2020 and Mar 2022. Pregnant women recruited will be randomized into two groups. The intervention group will receive lifestyle intervention; whereas the control group will receive regular surveillance only. Only intervention group will have diet education and exercise goal. They will go to dietitian OPD twice at GA 30-31+6 and 33-34+6 for Mediterranean diet education. As for exercise, participants in intervention group are asked to at least take 10000 steps 3 days a week. Diet modification and exercise intervention will persistent until delivery.
The primary end point is the change of biomarkers of preeclampsia and macrosomia, including maternal blood PlGF and sFLT1, and cord blood c-peptide, leptin, IGF-1, IGF-2, IGF-BP1 and IGF-BP3. The secondary end points include the change of frequency of adverse pregnancy outcomes, including individual outcome and the composite outcome, such as gestational hypertension, preeclampsia, preterm delivery, and large for gestational age (defined as birth weight ≥ 90th percentile), change of maternal body weight, change of maternal blood pressure, which is defined as 3 mm-Hg, change of maternal HOMA2-IR, change of maternal plasma triglyceride level and other lipid profile (total cholesterol, HDL, and LDL), echography finding of fetus, neonatal birth weight, change of glucose, and lipid profile (total cholesterol, HDL, LDL, and TG) of fetus cord blood, placental expression of preeclampsia (PlGF, sFLT1) and growth factors (IGF-1, 2, BP1 and BP3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women older than 20-year-old
- •During GA 24-28+6 weeks
- •Carrying a singleton
- •Having hypertriglyceridemia (plasma triglyceride at GA 24-28+6 excess 246 mg/dL but not higher than 1000 mg/dL).
排除标准
- •Using steroid
- •Using anti-platelet or anti-coagulant
- •Using lipid-lowering agents
- •Hypertriglyceridemia is caused by secondary cause, such as hypothyroidism, cushing syndrome, nephrotic syndrome, alcohol use or medication use.
- •Have been diagnosed with chronic hypertension, overt diabetes mellitus, gestational diabetes mellitus, secondary hypertriglyceridemia, autoimmune disease, or malignancy.
- •Have received the artificial fertilization.
- •Not having fetus echography examination at GA 22-23+6
- •Not going to deliver the baby at National Taiwan University Hospital
- •Have underwent other clinical trials
结局指标
主要结局
Change of biomarkers of preeclampsia
时间窗: Through study completion, an average of 2 year
including maternal blood PlGF (pg/mL) and sFLT1 (pg/mL)
Change of biomarkers of macrosomia
时间窗: Through study completion, an average of 2 year
such as cord blood c-peptide (μg/L)
次要结局
- Change of frequency of adverse pregnancy outcomes, including individual outcome and the composite outcome(Through study completion, an average of 2 year)
- Change of lipid profile of fetus cord blood(Through study completion, an average of 2 year)
- Neonatal birth weight(Through study completion, an average of 2 year)
- Placental protein expression (immunohistochemistry or western blot) of growth factors(Through study completion, an average of 2 year)
- Change of maternal body weight(Through study completion, an average of 2 year)
- Change of maternal plasma triglyceride level (mg/dL) and other lipid profile (total cholesterol, HDL, and LDL)(Through study completion, an average of 2 year)
- Change of maternal blood pressure(Through study completion, an average of 2 year)
- Change of maternal homeostatic model assessment 2 insulin resistance indexes (HOMA2-IR)(Through study completion, an average of 2 year)
- Change of glucose level of fetus cord blood(Through study completion, an average of 2 year)
- Placental protein expression (immunohistochemistry or western blot) of preeclampsia biomarkers(Through study completion, an average of 2 year)
- Echography finding of fetus(Through study completion, an average of 2 year)