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NCT Number: NCT05625750

Observational Study About Patients Diagnosed With NAFLD

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Infectious Disease, Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with nonalcoholic fatty liver disease

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. BMI

    Time frame: 3 weeks

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

  2. alcohol intake

    Time frame: 3 years

    alcohol consumption every week

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Nov 23, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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