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Observational Study About Patients Diagnosed With NAFLD

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05625750
Collaborator
(none)
500
Enrollment
1
Location
60
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. The largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (TG) content showed that approximately 33% of individuals have hepatic steatosis. NAFLD encompasses a continuum of histological findings that starts with steatosis that can progress to nonalcoholic steatohepatitis (NASH), which is characterized by inflammation and cell death, and eventually cirrhosis. Given the large number of individuals afflicted with this condition, there is a clear need to develop effective and safe therapies to treat NAFLD.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with NAFLD were recruited in the current study and divided into NAFLD group, and NASH group. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to ALT, AST, TG, TC, etc. Characteristic and prognosis of patients will be recorded. The serum, feces, urine and liver (if necessary) samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease
    Actual Study Start Date :
    Apr 27, 2022
    Anticipated Primary Completion Date :
    Apr 27, 2025
    Anticipated Study Completion Date :
    Apr 27, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Patients diagnosed with NAFLD

    All subjects will receive the currently recognized routine test of NAFLD according to their disease and no additional intervention and treatment will be added for subjects

    Outcome Measures

    Primary Outcome Measures

    1. BMI [3 weeks]

      BMI stands for body mass index. This is the ratio of a person's height to their weight.

    2. alcohol intake [3 years]

      alcohol consumption every week

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. patients diagnosed with nonalcoholic fatty liver disease
    Exclusion Criteria:

    1. patients suspected of excessive alcohol consumption

    2. malignant tumors, dementia, active tuberculosis, AIDS, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation

    3. incomplete data such as HBV serological results and abdominal ultrasound results

    4. patients who refuse to sign informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Infectious Disease, Xiangya Hospital, Central South University Changsha Hunan China 410008

    Sponsors and Collaborators

    • Xiangya Hospital of Central South University

    Investigators

    • Study Director: Yan Huang, Xiangya Hospital of Central South University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Huang Yan, Professor, Xiangya Hospital of Central South University
    ClinicalTrials.gov Identifier:
    NCT05625750
    Other Study ID Numbers:
    • Xiangya NAFLD project
    First Posted:
    Nov 23, 2022
    Last Update Posted:
    Nov 30, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Huang Yan, Professor, Xiangya Hospital of Central South University
    Nonalcoholic Fatty Liver Disease
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Nov 30, 2022