Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Non Alcoholic Fatty Liver Disease
  • Obesity
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 6 years and 18 years
Gender
Both males and females

Description

The investigators will perform a prospective comparison of the genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD in a cohort of obese children and adolescents. [Subjects] Obesity is defined as the BMI value > 95 percentile by different age-...

The investigators will perform a prospective comparison of the genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD in a cohort of obese children and adolescents. [Subjects] Obesity is 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. The investigators will measure total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase fasting glucose, triglyceride, total cholesterol, and high-density lipoprotein cholesterol, insulin, glucose, and adiponectin. [Liver ultrasonography] All participants will receive an ultrasonographic study of the liver. NAFLD is 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. [Genotyping] Genomic DNA will be extracted from 3 cc venous blood from each participant. After extraction, the genomic DNA will be immediately stored at -80°C. The TaqMan genotyping assays will be performed for selected SNPs genotyping on ABI 7300 Real-Time PCR System (Applied Biosystems). [Sample size] Sample size was estimated by Epi InfoTM 7 (CDC, USA) program. Because there was no previous data regarding to the effect of autophagy related gene on NAFLD, the investigators estimate the odds ratio to vary between 60-80%. The investigators used a confidence level of 95%, power of 80%, the ratio of controls to NAFLD cases of 25%, percent of controls exposed of 25-35%, the samples size required would be a total of 291-872 subjects.

Tracking Information

NCT #
NCT01988441
Collaborators
Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: Yu-Cheng Lin, M.D., Ph.D. Far Eastern Memorial Hospital