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

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).

Study Overview

• Status: Unknown
• Conditions: Hypertriglyceridemia During Pregnancy
• Intervention / Treatment: Behavioral: Lifestyle including optimal exercise and diet modification.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Intervention group receives lifestyle intervention for hypertriglyceridemia.	Behavioral: Lifestyle including optimal exercise and diet modification.; The intervention group will receive diet education and be given exercise suggestion.
NO_INTERVENTION: Control; Control group receives regular surveillance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of biomarkers of preeclampsia	including maternal blood PlGF (pg/mL) and sFLT1 (pg/mL)	Through study completion, an average of 2 year
Change of biomarkers of macrosomia	such as cord blood c-peptide (μg/L)	Through study completion, an average of 2 year
Change of biomarkers of macrosomia	such as cord blood leptin (ng/mL)	Through study completion, an average of 2 year
Change of biomarkers of macrosomia	such as cord blood IGF-1 (ng/mL), IGF-2 (ng/mL)	Through study completion, an average of 2 year
Change of biomarkers of macrosomia	such as cord blood IGF-BP1 (μg/mL), and IGF-BP3 (μg/mL)	Through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 2 year
Change of maternal body weight	Maternal body weight change (kilograms)	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)	Other lipid profile including total cholesterol (mg/dL), HDL (mg/dL), and LDL (mg/dL)	Through study completion, an average of 2 year
Change of maternal blood pressure	which is defined as 3 mm-Hg	Through study completion, an average of 2 year
Change of maternal homeostatic model assessment 2 insulin resistance indexes (HOMA2-IR)	Maternal HOMA2-IR change. The higher level of HOMA2-IR means the higher risk for insulin resistance.	Through study completion, an average of 2 year
Change of glucose level of fetus cord blood	Change of glucose level (mg/dL) of fetus cord blood	Through study completion, an average of 2 year
Change of lipid profile of fetus cord blood	including TG (mg/dL), total cholesterol (mg/dL), HDL (mg/dL), and LDL (mg/dL)	Through study completion, an average of 2 year
Echography finding of fetus	including biparietal diameter (mm), femur length (mm), head circumference (mm), and abdominal circumference (mm)	Through study completion, an average of 2 year
Echography finding of fetus	including estimated fetal weight (gm)	Through study completion, an average of 2 year
Neonatal birth weight	Neonatal birth weight (grams)	Through study completion, an average of 2 year
Placental protein expression (immunohistochemistry or western blot) of preeclampsia biomarkers	including PlGF and sFLT1	Through study completion, an average of 2 year
Placental protein expression (immunohistochemistry or western blot) of growth factors	including IGF-1, IGF-2, IGF-BP1, and IGF-BP3	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (ACTUAL): February 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: 201906001RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No