Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01988441 |
| Other study ID # |
102066-F |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2013 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Far Eastern Memorial Hospital |
| Contact |
Yu-Cheng Lin, M.D., Ph.D. |
| Phone |
+886-89667000 |
| Email |
q92421006[@]ntu.edu.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver
disease worldwide. It is not known why only some obese subjects develop NAFLD. In recent
years, a growing body of evidence showed a crucial role of autophagy in in the regulation of
liver fat storage. The purpose of this study is to determine whether autophagy
pathway-related genetic polymorphisms affect NAFLD.
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- 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.
