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Status unknownNCT02276144Updated Mar 20, 2020

Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

An observational study in Fatty Liver and Gestational Diabetes, sponsored by Seoul National University Hospital. Status unknown at 3 sites in Korea, Republic of. Open to female participants. Per ClinicalTrials.gov, last updated 2020-03-20.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,400
Sex
Female
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Study summary

The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk of pregnancy complications.

Read the detailed description

In cases in which metabolic syndrome and non-alcoholic fatty liver are risk factors of obstetric complications, such as gestational diabetes (GDM) or preeclampsia (PE), we are able to offer systematic clinical results from determining the independent risk factor and developing a predictable model. Recently, obstetric complications, especially GDM and PE, have increased due to the growth of elder pregnancy. In addition, as liver dysfunction has been known to be an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction, its clinical importance has risen. Metabolic syndromes, such as obesity, hypertension, type II diabetes and abnormal lipid profile, have been known for its importance in development of non-alcoholic fatty liver disease. Considering abnormal liver function being an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction in normal adult patients, we are able to predict that liver dysfunction might be a high risk factor of obstetric complications in pregnant women. In previous studies, the frequency of liver dysfunction in normal pregnant women was obtained.

The purpose of this current study was to investigate the prevalence of metabolic syndrome, abnormal liver function and non-alcoholic fatty liver in early pregnancy and the related risks of obstetric complications.

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Conditions studied

03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's planned enrollment of 2,400 is above the median of 140 across 397 observational studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

1st trimester pregnancy women with singleton

Inclusion criteria

  • Outpatient clinic patients of Seoul National University Hospital, Seoul Metropolitan Government Boramae Medical Center, Incheon Seoul Woman Hospital
  • Agree with this study
  • Do not drink excess amount of alcohol for recent 2 years

Exclusion criteria

Exclusion Criteria:

  • Do not agree with this study
  • Do not perform blood tests
  • Have underlying hepatobiliary diseases
  • Take medications which can cause liver abnormalities
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherLiver ultrasound

    For evaluate whether fatty liver is exist or not

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What researchers measure

Primary outcomes

  1. Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women

    Obstetrical complications include gestational diabetes, preeclampsia, etc Non-alcoholic fatty liver diagnosed by using liver ultrasound result of 1st trimester and blood test (AST, APT)

    Time frame: From date of enrollment until the date of delivery, assessed up to 35wks

07

Study locations

3 of 3 sites recruiting
  • Seoul Women's Hospital
    Incheon, 402859, Korea, Republic of
    • Ja Nam Koo, M.D · Contact · 010-8355-2180
    Recruiting
  • Seoul National University Hospital
    Seoul, 110744, Korea, Republic of
    • Joong Shin Park, MD PhD · Contact
    • Sun Min Kim, MD · Contact
    Recruiting
  • Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
    Seoul, 156707, Korea, Republic of
    • Seung Mi Lee, M.D, Ph.D. · Contact
    Recruiting
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References and documents

Publications

  • Lee SM, Hwangbo S, Norwitz ER, Koo JN, Oh IH, Choi ES, Jung YM, Kim SM, Kim BJ, Kim SY, Kim GM, Kim W, Joo SK, Shin S, Park CW, Park T, Park JS. Nonalcoholic fatty liver disease and early prediction of gestational diabetes mellitus using machine learning methods. Clin Mol Hepatol. 2022 Jan;28(1):105-116. doi: 10.3350/cmh.2021.0174. Epub 2021 Oct 15. PubMed 34649307 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02276144
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
Oct 28, 2014
Start date
Nov 2014
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Mar 20, 2020

Study contacts

JEONGEUN Kwon, MD
Contact
ccoolicoola@gmail.com
82-02-2072-3085
Joong Shin Park, MD PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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