Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

• Conditions: Fatty Liver; Gestational Diabetes

• Registration Number: NCT02276144
• Lead Sponsor: Seoul National University Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-28
• Study Start: 2014-11
• Status Verified: 2019-04
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-20
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2400

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women	From date of enrollment until the date of delivery, assessed up to 35wks	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)

Trial Locations

Locations (3)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Women's Hospital; 🇰🇷 Incheon, Korea, Republic of

Seoul Metropolitan Goverment Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of