Observational Study About Patients Diagnosed With NAFLD

NCT ID: NCT05625750

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2027-04-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nonalcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Huang Yan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Huang

Role: STUDY_DIRECTOR

Xiangya Hospital of Central South University

Locations

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Department of Infectious Disease, Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Huang

Role: CONTACT

+86 13874854142

Facility Contacts

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Yan Huang

Role: primary

+86 13874854142

References

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Wang S, Zhu Q, Liang G, Franks T, Boucher M, Bence KK, Lu M, Castorena CM, Zhao S, Elmquist JK, Scherer PE, Horton JD. Cannabinoid receptor 1 signaling in hepatocytes and stellate cells does not contribute to NAFLD. J Clin Invest. 2021 Nov 15;131(22):e152242. doi: 10.1172/JCI152242.

Reference Type BACKGROUND
PMID: 34499619 (View on PubMed)

Other Identifiers

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Xiangya NAFLD project

Identifier Type: -

Identifier Source: org_study_id

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