To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease
(1) Type 2 diabetes diagnosed according to WHO diagnostic criteria, age ≥ 18 years old, ≤ 70 years old, gender unlimited (2) Diagnosed with NAFLD according to the criteria of the "Guidelines for the Prevention and Treatment of Non alcoholic Fatty Liver Disease (2018 Updated Edition)" (3) Before screening, patients with type 2 diabetes who were treated with single or combined drugs of stable dose (except TZDs, SGLT2i, GLP-1RA, insulin and GKAs) for ≥ 8 weeks and had poor blood glucose control, 7% ≤ HbA1c ≤ 10% (4)BMI≥24 kg/m2 (5) Can understand the content and methods of this study and voluntarily sign an informed consent form
Alanine aminotransferase>2.0 times ULN and/or aspartate aminotransferase>2.0 times ULN and/or total bilirubin>2.0 times ULN
Blood ketones>ULN
eGFR <30ml/min/1.73 m2； Note: The formula for calculating eGFR is CKD-EPI (which can be calculated within the WeChat mini program)
Blood creatine kinase>3 times ULN (16) In addition to the above, the researchers have determined that patients who are not suitable to participate in this clinical trial
Single group
Addition of Hengge Liejing treatment for 48 weeks
DrugTreatment with Hengge Liejing for 48 weeks, drug formulation: tablets. Dosage: 10mg qd, taken orally in the morning, before or after breakfast, for 48 consecutive weeks
After 48 weeks of Henggeleijing treatment, FIB-4 index values
Four indicators of liver fibrosis after 48 weeks of Henggelijing treatment
FIB-4 index is a non-invasive liver fibrosis assessment tool based on blood indicators and age, mainly used to evaluate the risk of liver fibrosis progression in patients with chronic liver disease. Calculation formula: FIB-4=(age x AST)/(platelet count x √ ALT). When calculating, please note that the units of AST and ALT should be U/L, and the unit of platelet count should be 10 \^ 9/L。 When FIB-4\<1.3, it indicates no significant liver fibrosis When 1.3 ≤ FIB-4 ≤ 3.25, there may be moderate liver fibrosis When FIB-4\>3.25, there is a high suspicion of advanced liver fibrosis or cirrhosis
Improvement rate of FIB-4 index (FIB-4 index improvement defined as a decrease of ≥ 10% from baseline) after 48 weeks of treatment with Henggeleijing
Changes in visceral fat content compared to baseline after 48 weeks of treatment with Henggelijing
Using DUAL bioimpedance method to identify adipose tissue and subcutaneous fat, and safely and conveniently calculate visceral fat area
The results of glycated hemoglobin after 12, 24, and 48 weeks of Henggeleijing treatment
Incidence of Adverse events checklist(Safety during Henggeleijing treatment)
Fill in the adverse event record form truthfully, recording the subjects, follow-up time, coding language, occurrence time, severity, duration, relationship with treatment, measures taken, and outcome of the adverse event
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