Type 2 diabetes mellitus with nonalcoholic fatty liver disease
Conditions
Interventions
experimental group:Semaglutide + Jinying Sizi Tiaotai prescription
control group:Semaglutide
Sponsors
Shijiazhuang Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) meet the above Western diagnostic criteria for type 2 diabetes combined with non-alcoholic fatty liver disease (mild); (2) In line with the above Qi-Yin deficiency, turbid-toxin accumulation type 2 diabetes combined with non-alcoholic fatty liver disease TCM diagnostic criteria; (3) Age between 18 and 65 years old, gender unlimited, BMI of 25 to 35; (4) glycosylated hemoglobin in 7~10%; (5) Nonalcoholic hepatic steatosis, also known as simple fatty liver disease: bullovesicular or bullo-dominated fatty degeneration involves more than 5% of liver cells and can be accompanied by mild nonspecific inflammation; (6) Early non-alcoholic steatohepatitis: no liver fibrosis or only mild fibrosis F0~1; (7) Have a follow-up phone number and address, and the patient and the patient's family voluntarily cooperate with the interviewer.
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes; (2) Type 2 diabetes with poor glycemic control (HBA1c > 10%); (3) Severe liver function damage caused by any cause: liver enzyme ALT or AST >= 5 times the upper limit of normal; (4) Other forms of liver disease, including hepatitis B, hepatitis C and autoimmune hepatitis; (5) Excessive drinking: women drink more than 14 units per week, men drink more than 21 units per week; (6) Taking hypoglycemic drugs such as thiazolidinediones that affect hepatic steatosis within the past 3 months; a-glycosidase inhibitors; SGLT2 inhibitor; Any GLP-1 receptor agonist; Take medications such as vitamin E or folic acid; (7) Patients with contraindications to the use of semaglutide, such as medullary thyroid cancer history or family history; Patients with type 2 multiple endocrine tumor syndrome; (8) A clinically relevant history of gastrointestinal disorders associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and uncontrolled gastroesophageal reflux disease in the 6 months prior to screening; (9) Taking prescription or over-the-counter weight loss drugs within 3 months prior to screening; (10) Participants who have participated in any semaglutide clinical trial within the 3 months prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI;WHR;FBG;FINS;HbA1C;TC;TG;Intestinal flora;Abdominal color ultrasound; | — |
Secondary
| Measure | Time frame |
|---|---|
| AST;IL-6;TCM syndrome integral; | — |
Countries
China
Contacts
Public ContactDi Wu
Shijiazhuang Hospital of Traditional Chinese Medicine
Outcome results
None listed