Hypertriglyceridemia During PregnancyNCT04275622
The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome
A study testing Lifestyle including optimal exercise and diet modification. in people with Hypertriglyceridemia During Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Hypertriglyceridemia During Pregnancy
- What is being tested?
- Lifestyle including optimal exercise and diet modification.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Hypertriglyceridemia During Pregnancy
- Being tested
- Lifestyle including optimal exercise and diet modification.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle including optimal exercise and diet modification.Behavioural
The intervention group will receive diet education and be given exercise suggestion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group receives lifestyle intervention for hypertriglyceridemia. Receives: Behavioral: Lifestyle including optimal exercise and diet modification. |
| Control | No intervention | Control group receives regular surveillance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of biomarkers of preeclampsia
including maternal blood PlGF (pg/mL) and sFLT1 (pg/mL)
Measured: Through study completion, an average of 2 year
Change of biomarkers of macrosomia
such as cord blood c-peptide (μg/L)
Measured: Through study completion, an average of 2 year
Change of biomarkers of macrosomia
such as cord blood leptin (ng/mL)
Measured: 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)
Measured: 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)
Measured: Through study completion, an average of 2 year
Secondary outcomes (12)
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
Measured: Through study completion, an average of 2 year
Change of maternal body weight
Maternal body weight change (kilograms)
Measured: 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)
Measured: Through study completion, an average of 2 year
Change of maternal blood pressure
which is defined as 3 mm-Hg
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: Through study completion, an average of 2 year
Echography finding of fetus
including estimated fetal weight (gm)
Measured: Through study completion, an average of 2 year
Neonatal birth weight
Neonatal birth weight (grams)
Measured: Through study completion, an average of 2 year
Placental protein expression (immunohistochemistry or western blot) of preeclampsia biomarkers
including PlGF and sFLT1
Measured: 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
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertriglyceridemia During PregnancyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275622
- Sponsor's protocol ID
- 201906001RINC
- Status last verified
- Nov 2019
- First submitted
- 9 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome: the LITAPO Randomized Trial
- ClinicalTrials.gov ID
- NCT04275622
- Acronym / sponsor ID
- 201906001RINC
- Conditions
- Hypertriglyceridemia During Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle including optimal exercise and diet modification.Intervention group receives lifestyle intervention for hypertriglyceridemia. |
| Control | No intervention | –Control group receives regular surveillance. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle including optimal exercise and diet modification.The intervention group will receive diet education and be given exercise suggestion. | Behavioural | Intervention |
Primary outcome
Change of biomarkers of preeclampsia
Time frame: Through study completion, an average of 2 year
including maternal blood PlGF (pg/mL) and sFLT1 (pg/mL)
Change of biomarkers of macrosomia
Time frame: Through study completion, an average of 2 year
such as cord blood c-peptide (μg/L)
Change of biomarkers of macrosomia
Time frame: Through study completion, an average of 2 year
such as cord blood leptin (ng/mL)
Change of biomarkers of macrosomia
Time frame: Through study completion, an average of 2 year
such as cord blood IGF-1 (ng/mL), IGF-2 (ng/mL)
Change of biomarkers of macrosomia
Time frame: Through study completion, an average of 2 year
such as cord blood IGF-BP1 (μg/mL), and IGF-BP3 (μg/mL)
12 secondary outcomes
Change of frequency of adverse pregnancy outcomes, including individual outcome and the composite outcome
Time frame: Through study completion, an average of 2 year
Change of maternal body weight
Time frame: 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)
Time frame: Through study completion, an average of 2 year
Change of maternal blood pressure
Time frame: Through study completion, an average of 2 year
Change of maternal homeostatic model assessment 2 insulin resistance indexes (HOMA2-IR)
Time frame: Through study completion, an average of 2 year
Change of glucose level of fetus cord blood
Time frame: Through study completion, an average of 2 year
Change of lipid profile of fetus cord blood
Time frame: Through study completion, an average of 2 year
Echography finding of fetus
Time frame: Through study completion, an average of 2 year
Echography finding of fetus
Time frame: Through study completion, an average of 2 year
Neonatal birth weight
Time frame: Through study completion, an average of 2 year
Placental protein expression (immunohistochemistry or western blot) of preeclampsia biomarkers
Time frame: Through study completion, an average of 2 year
Placental protein expression (immunohistochemistry or western blot) of growth factors
Time frame: Through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle including optimal exercise and diet modification. in people with Hypertriglyceridemia During Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Yuan Li, MD, PhD (886-02-23123456 ext. 63540, larsli@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of biomarkers of preeclampsia (time frame: Through study completion, an average of 2 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.