Fatty LiverNCT02276144
Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
An observational study of Fatty Liver and Gestational Diabetes, run by Seoul National University Hospital at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fatty Liver, Gestational Diabetes
- What is being tested?
- Liver ultrasound
- How many people
- 2,400 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Nov 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1st trimester pregnancy women with singleton
Who may be able to join
- 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
Who cannot join
- Do not agree with this study
- Do not perform blood tests
- Have underlying hepatobiliary diseases
- Take medications which can cause liver abnormalities
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul Women's Hospital
Incheon, 402859
Ja Nam Koo, M.D, 010-8355-2180
- Recruiting
Seoul National University Hospital
Seoul, 110744
Joong Shin Park, MD PhD
Sun Min Kim, MD
- Recruiting
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
Seoul, 156707
Seung Mi Lee, M.D, Ph.D.
About this study
Official title: Investigation on the Frequency and Obstetric Significance of Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
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.
Read the 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.
- Conditions
- Fatty Liver, Gestational Diabetes
- Being tested
- Liver ultrasound
- Medical subject headings
- Fatty Liver, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver ultrasoundOther
For evaluate whether fatty liver is exist or not
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From date of enrollment until the date of delivery, assessed up to 35wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joong Shin Park, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276144
- Sponsor's protocol ID
- Fatty liver in pregnancy
- Status last verified
- Apr 2019
- First submitted
- 10 Oct 2014
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang D, Shen Y, Shuai R. Association between AST/ALT ratio and the risk of gestational diabetes mellitus in Korean pregnant women. PLoS One. 2025 Aug 29;20(8):e0331484. doi: 10.1371/journal.pone.0331484. eCollection 2025.
PubMed 40880520Zhang 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.
PubMed 38970008Lee 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.
PubMed 34649307
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Frequency and Obstetric Significance of Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
- ClinicalTrials.gov ID
- NCT02276144
- Acronym / sponsor ID
- Fatty liver in pregnancy
- Conditions
- Fatty Liver, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1st trimester pregnancy women with singleton
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Do not agree with this study
- Do not perform blood tests
- Have underlying hepatobiliary diseases
- Take medications which can cause liver abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver ultrasoundFor evaluate whether fatty liver is exist or not | Other | – |
Primary outcome
Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 40880520Yang D, Shen Y, Shuai R. Association between AST/ALT ratio and the risk of gestational diabetes mellitus in Korean pregnant women. PLoS One. 2025 Aug 29;20(8):e0331484. doi: 10.1371/journal.pone.0331484. eCollection 2025.
- Derived from this study: PubMed 38970008Zhang 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.
- Derived from this study: PubMed 34649307Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joong Shin Park, MD PhD principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and Gestational Diabetes, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JEONGEUN Kwon, MD (82-02-2072-3085, ccoolicoola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women (time frame: From date of enrollment until the date of delivery, assessed up to 35wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02276144, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.