Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

NCT ID: NCT02276144

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fatty Liver Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Liver ultrasound

For evaluate whether fatty liver is exist or not

Intervention Type OTHER

Eligibility Criteria

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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

* Do not agree with this study
* Do not perform blood tests
* Have underlying hepatobiliary diseases
* Take medications which can cause liver abnormalities
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joong Shin Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul Women's Hospital

Incheon, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JEONGEUN Kwon, MD

Role: CONTACT

82-02-2072-3085

Facility Contacts

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Ja Nam Koo, M.D

Role: primary

010-8355-2180

Joong Shin Park, MD PhD

Role: primary

Sun Min Kim, MD

Role: backup

Seung Mi Lee, M.D, Ph.D.

Role: primary

References

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Zhang J, Suo Y, Wang L, Liu D, Jia Y, Fu Y, Fan W, Jiang Y. Association between atherogenic index of plasma and gestational diabetes mellitus: a prospective cohort study based on the Korean population. Cardiovasc Diabetol. 2024 Jul 5;23(1):237. doi: 10.1186/s12933-024-02341-9.

Reference Type DERIVED
PMID: 38970008 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34649307 (View on PubMed)

Other Identifiers

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Fatty liver in pregnancy

Identifier Type: -

Identifier Source: org_study_id

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