Obesity Clinical Trial - The Influence of Autophagy on Fatty Liver

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Fatty Liver
Liver Diseases
Non-alcoholic Fatty Liver Disease
Obesity

Clinical Trial Details

NCT number	NCT01988441
Study type	Observational [Patient Registry]
Source	Far Eastern Memorial Hospital
Contact	Yu-Cheng Lin, M.D., Ph.D.
Phone	+886-89667000
Email	q92421006@ntu.edu.tw
Status	Recruiting
Phase
Start date	September 2013
Completion date	August 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.