NCT01988441

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

11.9 years

First QC Date

November 7, 2013

Last Update Submit

September 12, 2023

Conditions

Non-alcoholic Fatty Liver DiseaseObesity

Keywords

autophagychildrenpolymorphism

Outcome Measures

Primary Outcomes (1)

  • The genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD

    The genotype distribution of autophagy pathway-related genetic polymorphisms between those with and without NAFLD

    One year

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Obese Taiwanese children and adolescents

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, WBC DNA

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesity

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Cheng Lin, M.D., Ph.D.

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Cheng Lin, M.D., Ph.D.

CONTACT

+886-89667000q92421006@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 20, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

TW(1)