Diabete Type 2, NAFLD
Conditions
Brief summary
To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease
Interventions
DRUGAddition of Hengge Liejing treatment for 48 weeks
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
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* (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
Exclusion criteria
* (1) Patients with diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes (2) Acute diabetes complications such as diabetes ketosis or ketoacidosis, diabetes hypertonic state, diabetes lactic acidosis or serious chronic diabetes complications (3) Individuals with a history of recurrent urinary tract infections and/or genital infections (as determined by clinical physicians) (4) Alcoholic liver disease (alcohol consumption equivalent to less than 30 g/d for males and less than 20 g/d for females in the past two years) (5) Exclude other liver diseases, such as chronic hepatitis B, chronic hepatitis C, primary cholestatic cirrhosis, ballistic obstructive diseases, drug-induced liver damage, hemochromatosis, hepatolenticular deformation, autoimmune hepatitis (6) Combined cirrhosis, combined liver cancer, HIV positive, drug abuse (7) Drugs (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoid, etc.), total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, β - lipoprotein deficiency, lipoatrophic diabetes, Mauriac syndrome, and other special conditions leading to fatty liver (8) Serious trauma or acute infection that may affect blood glucose control occurred within 4 weeks (9) Individuals who have experienced decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or have undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months (10) There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any diseases that cause hemolysis or red blood cell instability (such as malaria, hemolytic anemia) (11) Individuals with severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery) (12) Uncontrolled hyperthyroidism (13) Individuals with mental or neurological disorders who are unwilling to communicate or unable to fully understand and collaborate (14) Pregnant or lactating women (15) There are any laboratory test indicators that meet the following standards: 1. Alanine aminotransferase\>2.0 times ULN and/or aspartate aminotransferase\>2.0 times ULN and/or total bilirubin\>2.0 times ULN 2. Blood ketones\>ULN 3. eGFR \<30ml/min/1.73 m2； Note: The formula for calculating eGFR is CKD-EPI (which can be calculated within the WeChat mini program) 4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 48 weeks of Henggeleijing treatment, FIB-4 index values | From enrollment to the end of treatment at 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Four indicators of liver fibrosis after 48 weeks of Henggelijing treatment | From enrollment to the end of treatment at 48 weeks | 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 | 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 | From enrollment to the end of treatment at 48 weeks | 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 | 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 | From enrollment to the end of treatment at 48 weeks | — |
| Changes in fasting plasma glucose levels compared to baseline after 12, 24, 36, and 48 weeks of treatment with Henggeleijing | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From enrollment to the end of treatment at 48 weeks | — |
| FIB-4 index after 12,and 24 weeks of Henggeleijing treatment | From enrollment to the end of treatment at 24 weeks | — |
| After 48 weeks of Henggeleijing treatment, the fat content of the endocardial fat pad | From enrollment to the end of treatment at 48 weeks | Cardiac ultrasound detection of fat content in endocardial fat pad |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse events checklist(Safety during Henggeleijing treatment) | From enrollment to 14 days after the last administration | 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 |
Outcome results
None listed