The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome

National Taiwan University

Status

Unknown

Conditions

Hypertriglyceridemia During Pregnancy

Treatments

Behavioral: Lifestyle including optimal exercise and diet modification.

Study type

Interventional

Funder types

Other

Identifiers

NCT04275622

201906001RINC

Details and patient eligibility

About

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).

Enrollment

70 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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