Fatty LiverNCT00274183
Nonalcoholic Fatty Liver Disease in Taiwanese Children
An observational study of Fatty Liver, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Fatty Liver
- How many people
- 614 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to 31 Dec 2018
- 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 will be enrolled from elementary school and high school in Taiwan
Who may be able to join
- diagnosis of fatty liver
Who cannot join
- other hepatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children
Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem.
Read the detailed description
[Study Subjects] Obesity was defined as the BMI value > 95 percentile by different age- and gender groups according to the standards of the Department of Health in Taiwan.
[Data Collection] The following data were obtained for each subject: age, gender, BMI, waist and hip circumference. BMI was calculated as body weight (kg)/ height (m2).
In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total cholesterol,high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.
[Liver Ultrasonography] All participants underwent an ultrasonographic study of the liver performed by one operator.
NAFLD was defined as the presence of an ultrasonographic pattern consistent with the following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility of diaphragm, and obscure hepatic vessel structures.
- Conditions
- Fatty Liver
- Medical subject headings
- Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
non-alcoholic fatty liver disease
confirmed by liver ultrasonography
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Cheng Lin, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274183
- Sponsor's protocol ID
- 94034
- Status last verified
- Dec 2018
- First submitted
- 2 Jan 2006
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lin YC, Chang PF, Chang MH, Ni YH. Genetic variants in GCKR and PNPLA3 confer susceptibility to nonalcoholic fatty liver disease in obese individuals. Am J Clin Nutr. 2014 Apr;99(4):869-74. doi: 10.3945/ajcn.113.079749. Epub 2014 Jan 29.
PubMed 24477042Lin YC, Chang PF, Chang MH, Ni YH. A common variant in the peroxisome proliferator-activated receptor-gamma coactivator-1alpha gene is associated with nonalcoholic fatty liver disease in obese children. Am J Clin Nutr. 2013 Feb;97(2):326-31. doi: 10.3945/ajcn.112.046417. Epub 2012 Dec 26.
PubMed 23269818
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children
- ClinicalTrials.gov ID
- NCT00274183
- Acronym / sponsor ID
- 94034
- Conditions
- Fatty Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Jan 2006 (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.
Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem.
Detailed description
[Study Subjects] Obesity was defined as the BMI value > 95 percentile by different age- and gender groups according to the standards of the Department of Health in Taiwan.
[Data Collection] The following data were obtained for each subject: age, gender, BMI, waist and hip circumference. BMI was calculated as body weight (kg)/ height (m2).
In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total cholesterol,high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.
[Liver Ultrasonography] All participants underwent an ultrasonographic study of the liver performed by one operator.
NAFLD was defined as the presence of an ultrasonographic pattern consistent with the following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility of diaphragm, and obscure hepatic vessel structures.
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 will be enrolled from elementary school and high school in Taiwan
Key inclusion criteria (1 listed)
- diagnosis of fatty liver
Key exclusion criteria (1 listed)
- other hepatic diseases
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
non-alcoholic fatty liver disease
Time frame: one year
confirmed by liver ultrasonography
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 9 Apr 2019.
- Derived from this study: PubMed 24477042Lin YC, Chang PF, Chang MH, Ni YH. Genetic variants in GCKR and PNPLA3 confer susceptibility to nonalcoholic fatty liver disease in obese individuals. Am J Clin Nutr. 2014 Apr;99(4):869-74. doi: 10.3945/ajcn.113.079749. Epub 2014 Jan 29.
- Derived from this study: PubMed 23269818Lin YC, Chang PF, Chang MH, Ni YH. A common variant in the peroxisome proliferator-activated receptor-gamma coactivator-1alpha gene is associated with nonalcoholic fatty liver disease in obese children. Am J Clin Nutr. 2013 Feb;97(2):326-31. doi: 10.3945/ajcn.112.046417. Epub 2012 Dec 26.
- Individual participant dataSharing planned: Undecided
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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.
Yu-Cheng Lin, M.D. 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, 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 1 inclusion and 1 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 9 Apr 2019. 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?
non-alcoholic fatty liver disease (time frame: one year). 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 NCT00274183, which also lists 2 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 9 Apr 2019.