NCT07198516尚未招募1 期
The Improvement Effect of Henggliejin on Fatty Liver in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver: a Multicenter, Prospective, Single Arm Clinical Study
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 149
- 主要终点
- After 48 weeks of Henggeleijing treatment, FIB-4 index values
研究概览
简要总结
To evaluate the effect and safety of Henggliejin on fatty liver in type 2 diabetes patients with nonalcoholic fatty liver disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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
研究组 & 干预措施
Add Henggelijing treatment for T2DM patients with NAFLD and oral administration of three or fewer hy
Experimental
干预措施: Addition of Hengge Liejing treatment for 48 weeks (Drug)
结局指标
主要结局
After 48 weeks of Henggeleijing treatment, FIB-4 index values
时间窗: From enrollment to the end of treatment at 48 weeks
次要结局
- Four indicators of liver fibrosis after 48 weeks of Henggelijing treatment(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(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)
- 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)
- The results of glycated hemoglobin after 12, 24, and 48 weeks of Henggeleijing treatment(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)
- 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 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)
- 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)
- After 48 weeks of Henggeleijing treatment, the fat content of the endocardial fat pad(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 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)
- 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 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)
- FIB-4 index after 12,and 24 weeks of Henggeleijing treatment(From enrollment to the end of treatment at 24 weeks)
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