Metabolic Associated Fatty Liver Disease Clinical Trial
Official title:
Lifestyle Modification for the Treatment of Metabolic Associated Fatty Liver Disease Based on Transtheoretical Model: a Single-center, Randomized, Controlled Study
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 improve the efficiency of weight loss. The investigators hypothesize that gut microbiota may affect motivation to lose weight, and the changes in gut microbiota due to weight loss may positively feedback the behavior of motivation, forming a virtuous circle. Thus, this study aims at ①evaluating the relationships between motivational stage of weight loss and the gut microbiota (Gut-brain axis); ②investigating the effects of lifestyle interventions on the gut microbiota in MAFLD patients.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 30, 2024 |
Est. primary completion date | May 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. With age range of 18-65 years. 2. BMI = 28kg/m2 3. Fatty infiltration of the liver was confirmed on imaging studies (ultrasound, transient elastography, computed tomography, or magnetic resonance imaging) or liver biopsy. 4. With valid motivational stage assessment based on TTM. 5. Written consent form obtained. Exclusion Criteria: 1. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and Inherited metabolic liver diseases) and hemochromatosis. 2. Self-reported HIV-positive status, active tuberculosis, active malaria, or inflammatory bowel disease. 3. Excessive alcohol consumption (>30g/d for men and >20g/d for women). 4. Patient has known cirrhosis (compensated/decompensated) either based on clinical criteria or liver histology or Imaging techniques. 5. Subjects using thyroid hormones, oestrogens, amiodarone, steroids, tamoxifen and other medicine known to affect liver fat accumulation. 6. Subjects using thiazolidinedione hypoglycemic drugs, vitamin E and other medicine have potential benefits for NASH within six months. 7. Subjects with organ failure. 8. Subjects with hepatocellular carcinoma or other active malignancy. 9. Solid organ transplant recipients. 10. Antibiotic treatment within the previous 3 months. 11. Suffering from any acute or chronic cardiovascular, GI or immunological condition. 12. Gastric or duodenal ulcer in the past six months. 13. Currently pregnant or nursing. 14. Concomitant diseases with reduced life expectancy. 15. Combined mental illness. 16. Contraindication to MRI scanning. 17. Exclusions may also be made at the discretion of the attending physician or the eligibility committee. 18. Inability to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hepatic fat | Change of liver proton density fat fraction (PDFF) in MAFLD assessed by magnetic resonance imaging (MRI) | 12 months | |
Primary | Obesity | Changes in body weight | 1, 4, 8, 12, 24 months | |
Primary | Gut microbiota | Changes in bacterial component of the gut microbiome | 1, 4, 8, 12, 24 months | |
Secondary | Blood pressure | Changes in blood pressure | 1, 4, 8, 12, 24 months | |
Secondary | Central obesity | Changes in waist circumference | 1, 4, 8, 12, 24 months | |
Secondary | Insulin resistance | Changes in insulin resistance eveluated by HOMA-IR | 1, 4, 8, 12, 24 months | |
Secondary | FPG | Changes in fast plasma glucose | 1, 4, 8, 12, 24 months | |
Secondary | HbA1c | Changes in HbA1c | 1, 4, 8, 12, 24 months | |
Secondary | Plasma triglycerides | Changes in plasma triglycerides | 1, 4, 8, 12, 24 months | |
Secondary | Plasma HDL-cholesterol | Changes in plasma HDL-cholesterol | 1, 4, 8, 12, 24 months | |
Secondary | Plasma high-sensitivity C-reactive protein level | Changes in plasma high-sensitivity C-reactive protein level | 1, 4, 8, 12, 24 months | |
Secondary | Gut microbiota diversity | Changes in diversity of gut microbiome(a-diversity and ß-diversity) | 1, 4, 8, 12, 24 months |
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