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Characteristics of gut microbiota in patients with metabolism-related fatty liver disease

Characteristics of gut microbiota in patients with metabolism-related fatty liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100051634
Enrollment
Unknown
Registered
2021-09-28
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic-dysfunction-associated fatty liver disease

Interventions

health volunteers group:No
Group Patients with Metabolic-dysfunction-associated fatty liver disease:No
Group Overweight/obese patients with MAFLD:No
Group Lean/normal weight with metabolic dysfunction patients with MAFLD:No

Sponsors

Department of Gastroenterology, Shenzhen Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Aged 18-70 years old; 3. The subjects are willing to collect and send samples in strict accordance with the sampling procedures; 4. (Only applicable to healthy volunteers in the first phase of the study) vital signs, physical examination, blood routine, blood biochemistry, urinalysis All measurements were within the normal range or abnormal but the researchers considered insignificant abnormalities, and the body mass index was 19.0-23.0kg/m2 (including the cutoff value, calculation formula = weight/height 2), waist circumference =23kg/m2; (2) History of type 2 diabetes or fasting blood glucose >=7.0mmol/L; (3) Metabolic dysfunction, with at least two of the following risk factors for metabolic abnormalities: 1) Waist circumference: Asian men and women >=90 and 80cm respectively; 2) Blood pressure: >=130/85mmHg or receiving blood pressure lowering drug treatment; 3) Blood triglyceride: >=150mg/dL (>=1.70mmol/L) or receive blood lipid-lowering drug treatment; 4) Plasma high-density lipoprotein cholesterol: male = 2.5; 7) Blood hypersensitivity C-reactive protein: >2mg/L; 6. (Applicable to MAFLD patients in the second phase of the study) Diagnosed by imaging, blood biomarkers/NAS activity score (NAS pathology scoring system) or liver histology, diagnosed with hepatic steatosis, and combined with one of the following conditions : (1) Overweight/obesity: BMI>=23kg/m2; (2) Metabolic dysfunction, with at least two of the following risk factors for metabolic abnormalities: 1) Waist circumference: Asian men and women >=90 and 80cm respectively; 2) Blood pressure: >=130/85mmHg or receiving blood pressure lowering drug treatment; 3) Blood triglycerides: >=150 mg/dL (>=1.70 mmol/L) or receiving lipid-lowering drugs; 4) Plasma high-density lipoprotein cholesterol: male = 2.5; 7) Blood high-sensitivity C-reactive protein: >2mg/L.

Exclusion criteria

Exclusion criteria: 1. Present chronic diseases that may interfere with the study data, including but not limited to chronic infection, any intestinal diseases or symptoms (including but not limited to symptoms such as constipation and diarrhea and diseases such as colitis, Crohn's disease, intestinal obstruction and intestinal tumor); 2. Severe acute illness that may interfere with study data occurred in the month prior to screening; 3. Cirrhosis; 4. (phase II study only) fatty liver disease with type 2 diabetes; 5. Those who had used antibiotics within 3 months before the study began; 6. Had consumed a large amount of alcohol within 1 week prior to fecal sample collection (& GT; 1000 ml beer or gt; 200 ml of white wine) or significant changes in eating habits (e.g. sudden intake of large amounts of meat, vegetarian or industrially processed foods); 7. Subjects considered unsuitable for the study by the researcher, such as poor mental health, poor compliance, etc.

Design outcomes

Primary

MeasureTime frame
Differential bacteria in the gut;

Countries

China

Contacts

Public ContactZhu Ying

Shenzhen Hospital of Southern Medical University

zy_ww@163.com+86 13384662039

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026