To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
149
Treatment 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
Time frame: From enrollment to the end of treatment at 48 weeks
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
Time frame: From enrollment to the end of treatment at 48 weeks"
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
Time frame: From enrollment to the end of treatment at 48 weeks"
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
Time frame: From enrollment to the end of treatment at 48 weeks
The results of glycated hemoglobin after 12, 24, and 48 weeks of Henggeleijing treatment
Time frame: From enrollment to the end of treatment at 48 weeks
The proportion of HbA1c<7% and HbA1c<6.5% after 12, 24, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
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Changes in fasting plasma glucose levels compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
After 12, 24, 36, and 48 weeks of treatment with Henggeleijing, changes in liver enzyme indicators (including AST, ALT, GGT) compared to baseline were observed
Time frame: From enrollment to the end of treatment at 48 weeks
After 48 weeks of Henggeleijing treatment, the fat content of the endocardial fat pad
Cardiac ultrasound detection of fat content in endocardial fat pad
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in C-peptide levels compared to baseline after 12, 24, and 48 weeks of treatment with Henggelijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in fasting insulin levels compared to baseline after 12, 24, and 48 weeks of treatment with Henggelijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in HOMA-IR index compared to baseline after 12, 24, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in fasting body weight compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Blood pressure changes compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
Changes in blood lipid profile (including LDL-C, TG, HDL, TC) compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing
Time frame: From enrollment to the end of treatment at 48 weeks
FIB-4 index after 12,and 24 weeks of Henggeleijing treatment
Time frame: From enrollment to the end of treatment at 24 weeks