NCT05625750

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Apr 2022Apr 2027

Study Start

First participant enrolled

April 27, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2027

Expected
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

November 15, 2022

Last Update Submit

November 25, 2022

Conditions

Keywords

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • BMI

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

    3 weeks

  • alcohol intake

    alcohol consumption every week

    3 years

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the age of 18-75, who was diagnosed with NAFLD were all elligible for this observational study.

You may qualify if:

  • \. patients diagnosed with nonalcoholic fatty liver disease

You may not qualify if:

  • patients suspected of excessive alcohol consumption
  • malignant tumors, dementia, active tuberculosis, AIDS, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation
  • incomplete data such as HBV serological results and abdominal ultrasound results
  • patients who refuse to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Disease, Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34499619BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood including blood cells, serum and plasma, urine, faeces and liver tissue (if necessary)

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Yan Huang

    Xiangya Hospital of Central South University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

April 27, 2022

Primary Completion

April 27, 2025

Study Completion (Estimated)

April 27, 2027

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations