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Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

Investigation on the Frequency and Obstetric Significance of Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02276144
Enrollment
2400
Registered
2014-10-28
Start date
2014-11-30
Completion date
2021-12-31
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Gestational Diabetes

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.

Interventions

For evaluate whether fatty liver is exist or not

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant womenFrom date of enrollment until the date of delivery, assessed up to 35wksObstetrical complications include gestational diabetes, preeclampsia, etc Non-alcoholic fatty liver diagnosed by using liver ultrasound result of 1st trimester and blood test (AST, APT)

Countries

South Korea

Contacts

Primary ContactJEONGEUN Kwon, MD
ccoolicoola@gmail.com82-02-2072-3085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026