Clinical trial NCT02276144: Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
Official title: Investigation on the Frequency and Obstetric Significance of Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatty Liver
Gestational Diabetes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 2400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1st trimester pregnancy women with singleton

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women
timeFrame: From date of enrollment until the date of delivery, assessed up to 35wks
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Seoul Women's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Joong Shin Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.