Status:
UNKNOWN
Lifestyle Modification for MAFLD Based on TTM
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Metabolic Associated Fatty Liver Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Lifestyle changes aiming at weight loss remain the cornerstone of MAFLD treatment.Evaluating the motivational stage of patients' change and providing targeted lifestyle guidance may significantly impr...
Detailed Description
Fatty liver associated with metabolic dysfunction is common, affects a quarter of the population, and has no approved drug therapy. In 2020, two position articles have proposed not only the change of ...
Eligibility Criteria
Inclusion
- With age range of 18-65 years.
- BMI ≥ 28kg/m2
- Fatty infiltration of the liver was confirmed on imaging studies (ultrasound, transient elastography, computed tomography, or magnetic resonance imaging) or liver biopsy.
- With valid motivational stage assessment based on TTM.
- Written consent form obtained.
Exclusion
- History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and Inherited metabolic liver diseases) and hemochromatosis.
- Self-reported HIV-positive status, active tuberculosis, active malaria, or inflammatory bowel disease.
- Excessive alcohol consumption (\>30g/d for men and \>20g/d for women).
- Patient has known cirrhosis (compensated/decompensated) either based on clinical criteria or liver histology or Imaging techniques.
- Subjects using thyroid hormones, oestrogens, amiodarone, steroids, tamoxifen and other medicine known to affect liver fat accumulation.
- Subjects using thiazolidinedione hypoglycemic drugs, vitamin E and other medicine have potential benefits for NASH within six months.
- Subjects with organ failure.
- Subjects with hepatocellular carcinoma or other active malignancy.
- Solid organ transplant recipients.
- Antibiotic treatment within the previous 3 months.
- Suffering from any acute or chronic cardiovascular, GI or immunological condition.
- Gastric or duodenal ulcer in the past six months.
- Currently pregnant or nursing.
- Concomitant diseases with reduced life expectancy.
- Combined mental illness.
- Contraindication to MRI scanning.
- Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
- Inability to provide informed consent.
Key Trial Info
Start Date :
May 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04871880
Start Date
May 17 2020
End Date
December 30 2024
Last Update
May 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China