- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988441
The Influence of Autophagy on Fatty Liver
The Influence of Autophagy on Nonalcoholic Fatty Liver Disease
Study Overview
Status
Conditions
Detailed 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yu-Cheng Lin, M.D., Ph.D.
- Phone Number: 1538 +886-89667000
- Email: q92421006@ntu.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan, 220
- Recruiting
- Far Eastern Memorial Hospital
-
Principal Investigator:
- Yu-Cheng Lin, M.D., Ph.D.
-
Contact:
- Yu-Cheng Lin, M.D., Ph.D.
- Phone Number: 4449 886-89667000
- Email: q92421006@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Age 6-18 years old
- Obesity definition: BMI > 95% according to the age- and gender-specific standard by National Health Institute in Taiwan
- Willing to give written informed consent
Exclusion criteria:
- Alcohol consumption
- Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
- Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD
Time Frame: One year
|
The genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yu-Cheng Lin, M.D., Ph.D., Far Eastern Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102066-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted