The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver:

Official title

The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: a Multicenter, Prospective, Single Arm Clinical Study

Overview

To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease

Interventions

• Drug Addition 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

Primary outcome measures

• After 48 weeks of Henggeleijing treatment, FIB-4 index values [Time frame: From enrollment to the end of treatment at 48 weeks]

Secondary outcome measures (12)

• Four indicators of liver fibrosis after 48 weeks of Henggelijing treatment [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 [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]
• 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 [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]

Eligibility criteria

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:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07198516 · 2024XHYG0020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗