Hypertriglyceridemia During Pregnancy Clinical Trial
Official title:
The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome: the LITAPO Randomized Trial
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).
n/a