Fatty LiverNCT01682655
Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children
An observational study of Fatty Liver and Obesity, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise. Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Fatty Liver, Obesity
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Dec 2014
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Obese children and adolescents in Taiwan
Who may be able to join
- Age 6-18 years old
- Obesity definition: BMI > 95% according to the age- and gender-specific standard suggested by National Health Institute in Taiwan
- Willing to give written informed consent by parents
Who cannot join
- Alcohol consumption
- Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
- Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children
In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.
Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults.
The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP) influence fatty liver in obese children and adolescent.
Read the detailed description
The primary aim of this study is to assess the associations between to investigate the association of rs2854117 C > T and rs2854116 T > C SNPs of the APOC3 gene with liver steatosis, as measured by liver ultrasound.
As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C > T and rs2854116 T > C SNPs and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. In addition, the investigators will further analyze the association with other biomarkers, such as body mass index, adiponectin and insulin resistance.
- Conditions
- Fatty Liver, Obesity
- Medical subject headings
- Fatty Liver, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis
Measured: Oct 2013 ~ Dec 2014
Secondary outcomes (1)
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance
Measured: Oct 2013 ~ Dec 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Cheng Lin, MD, PhD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682655
- Sponsor's protocol ID
- 101015-F
- Status last verified
- Nov 2013
- First submitted
- 3 Sep 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children
- ClinicalTrials.gov ID
- NCT01682655
- Acronym / sponsor ID
- 101015-F
- Conditions
- Fatty Liver, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 2012 (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.
In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.
Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults.
The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP) influence fatty liver in obese children and adolescent.
Detailed description
The primary aim of this study is to assess the associations between to investigate the association of rs2854117 C > T and rs2854116 T > C SNPs of the APOC3 gene with liver steatosis, as measured by liver ultrasound.
As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C > T and rs2854116 T > C SNPs and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. In addition, the investigators will further analyze the association with other biomarkers, such as body mass index, adiponectin and insulin resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Obese children and adolescents in Taiwan
Key inclusion criteria (3 listed)
- Age 6-18 years old
- Obesity definition: BMI > 95% according to the age- and gender-specific standard suggested by National Health Institute in Taiwan
- Willing to give written informed consent by parents
Key exclusion criteria (3 listed)
- Alcohol consumption
- Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
- Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis
Time frame: Oct 2013 ~ Dec 2014
1 secondary outcome
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance
Time frame: Oct 2013 ~ Dec 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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.
Yu-Cheng Lin, MD, PhD principal investigator
Far Eastern Memorial Hospital
1 site 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 Obesity, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis (time frame: Oct 2013 ~ Dec 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.