Clinical trial NCT04275622: The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome
Official title: The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome: the LITAPO Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertriglyceridemia During Pregnancy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change of biomarkers of preeclampsia
timeFrame: Through study completion, an average of 2 year
measure: Change of biomarkers of macrosomia
timeFrame: Through study completion, an average of 2 year
measure: Change of biomarkers of macrosomia
timeFrame: Through study completion, an average of 2 year
measure: Change of biomarkers of macrosomia
timeFrame: Through study completion, an average of 2 year
measure: Change of biomarkers of macrosomia
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Change of frequency of adverse pregnancy outcomes, including individual outcome and the composite outcome
timeFrame: Through study completion, an average of 2 year
measure: Change of maternal body weight
timeFrame: Through study completion, an average of 2 year
measure: Change of maternal plasma triglyceride level (mg/dL) and other lipid profile (total cholesterol, HDL, and LDL)
timeFrame: Through study completion, an average of 2 year
measure: Change of maternal blood pressure
timeFrame: Through study completion, an average of 2 year
measure: Change of maternal homeostatic model assessment 2 insulin resistance indexes (HOMA2-IR)
timeFrame: Through study completion, an average of 2 year
measure: Change of glucose level of fetus cord blood
timeFrame: Through study completion, an average of 2 year
measure: Change of lipid profile of fetus cord blood
timeFrame: Through study completion, an average of 2 year
measure: Echography finding of fetus
timeFrame: Through study completion, an average of 2 year
measure: Echography finding of fetus
timeFrame: Through study completion, an average of 2 year
measure: Neonatal birth weight
timeFrame: Through study completion, an average of 2 year
measure: Placental protein expression (immunohistochemistry or western blot) of preeclampsia biomarkers
timeFrame: Through study completion, an average of 2 year
measure: Placental protein expression (immunohistochemistry or western blot) of growth factors
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: