Nonalcoholic Fatty Liver Disease in Taiwanese Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Far Eastern Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00274183
First received: January 2, 2006
Last updated: October 12, 2015
Last verified: September 2015
  Purpose
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.

Condition
Fatty Liver

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence, Clinicopathological Characteristics, Biomarkers and Genetics of Nonalcoholic Steatohepatitis in Taiwanese Children

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • non-alcoholic fatty liver disease confirmed by liver ultrasonography [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Serum, WBC DNA

Estimated Enrollment: 800
Study Start Date: January 2006
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obese children will be enrolled from elementary school and high school in Taiwan
Criteria

Inclusion Criteria:

  • diagnosis of fatty liver

Exclusion Criteria:

  • other hepatic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274183

Contacts
Contact: Yu-Cheng Lin, M.D. 886-2-89667000 ext 4449 q92421006@ntu.edu.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 220
Contact: Yu-Cheng Lin, MD    0931122487    q92421006@ntu.edu.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Yu-Cheng Lin, M.D. Far Eastern Memorial Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00274183     History of Changes
Other Study ID Numbers: 94034 
Study First Received: January 2, 2006
Last Updated: October 12, 2015
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 26, 2016