Type 2 diabetes patients with metabolic fatty liver disease
Conditions
Interventions
High dose intervention group:Metformin 1000mg+ Hengglizin 5mg twice/day
Control group (metformin group):Metformin 2000mg/day
Low dose intervention group:Metformin 1000mg+ Hengglizin 5mg 1 tablet/day
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.80 years old > age >=18 years old; 2.25kg/m^2=7.5%; Metformin therapy (750-1500mg) in patients with type 2 diabetes combined with metabolically associated fatty liver disease with poor glycemic control (HbAlc: 7.0-10.0%; Or FBG: 7.0-13.9mmol/L); 6.Fasting C-peptide >=1.1ng/ml, 2 hours after meals C-peptide >=2.5ng/ml; 7.The diagnostic criteria for MAFLD in the Guidelines for the Prevention and Treatment of Metabolically Associated Fatty Liver Disease (2018 Updated Edition) [2] were met. 8.No previous use of hypoglycemic drugs; 9.Newly diagnosed patients with type 2 diabetes.
Exclusion criteria
Exclusion criteria: 1.Refuse to participate in this study; 2.The female subject is pregnant or breastfeeding, or intends to become pregnant within 30 days before, during, or after the study, or is of childbearing age and is not using effective contraception; 3.Diabetic ketoacidosis was present; 4.Diabetic foot disease; 5.Hypotension, blood pressure 34.2µmol/L; 10.pancreatitis, pancreatic lipoma, or pancreatic stones. Had undergone gastrointestinal surgery that could cause indigestion and absorption; 11.Have metal objects in the body, or suffer from claustrophobia and cannot undergo MRI examination; 12.Active or untreated malignancy; 13.Unable to complete long-term follow-up or poor compliance; 14.Have participated or are participating in other clinical investigators within 1 month; 15.The investigator considers that there are any factors that affect the participant's participation in the trial or the evaluation of the results; 16.hypoglycemic agents, especially GLP-1 and TZD, are being used; 17.Other drugs for the treatment of MAFLD, diet drugs, immunomodulatory drugs, liver protection drugs, etc., are being used; 18.Rifampicin is being used; 19.Received any antibiotics or probiotics within 1 month; 20.Previous history of inflammatory bowel disease, gastrointestinal surgery, or cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content;Glycosylated Hemoglobin;pancreatic fat content; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine;intestinal metagenomic sequencing;Eight items of Liver function;Thyroid Function;glucose;C-Peptide;urinalysis;Insulin;Hepatitis etiology;Six items of renal function;Blood Lipids; | — |
Countries
China
Contacts
Public ContactXuejuan Xu
The First People's Hospital of Foshan
Outcome results
None listed