Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02276144
• Other study ID #: Fatty liver in pregnancy
• Status: Recruiting
• Start date: November 2014
• Est. completion date: December 2021

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: JEONGEUN Kwon, MD
• Phone: 82-02-2072-3085
• Email: ccoolicoola[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Fatty Liver
• Gestational Diabetes
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Liver ultrasound
For evaluate whether fatty liver is exist or not

Locations

Country	Name	City	State
Korea, Republic of	Seoul Women's Hospital	Incheon
Korea, Republic of	Seoul Metropolitan Goverment Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From date of enrollment until the date of delivery, assessed up to 35wks