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This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | Patients whose blood glucose are regulated by10 mg of Henagliflozein and metformin. |
|
| placebo | Placebo Comparator | Patients whose blood glucose are regulated by5mg of Linagliptin and metformin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henagliflozein and Metformin | Drug | The experimental group will be treated with 10mg Henagliflozein and Metformin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of liver enzymes (ALT). | 24 weeks | |
| The changes of liver enzymes (AST). | 24 weeks | |
| The changes of liver enzymes(GGT). |
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Inclusion Criteria:
Exclusion Criteria:
(1)Using drugs that may cause weight change 90 days before screening, including diuretics, weight-loss drug etc.; (2)Using drugs that may affect blood glucose for >1 week within 12 weeks, such as oral/intravenous glucocorticoid, growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc., but low-dose diuretics for antihypertensive purposes (hydrochlorothiazide < 25mg/d, indapamide < 1.5 mg/d) are not included in this restriction; (3)Had bariatric sugery or planning to have bariatric surgery; 10.The laboratory results of patients meet the following standards:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Chen, MD | Contact | 13602759769 | rubychq@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Chen, MD | Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C585596 | Jentadueto |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Linagliptin and Metformin | Drug | The control group will be treated with 5mg Linagliptin and Metformin. |
|
| 24 weeks |
| The changes of hepatic fibrosis indexes(glutathione reductase). | 24 weeks |
| The changes of hepatic fibrosis indexes(total bile acid). | 24 weeks |
| The changes of hepatic fibrosis indexes(fibronectin). | 24 weeks |
| The changes of hepatic fibrosis indexes(N-terminal brain of type I procollagen.). | 24 weeks |
| The changes of hepatic fibrosis indexes(hyaluronic acid). | 24 weeks |
| The changes of hepatic fibrosis indexes(laminin). | 24 weeks |
| The changes of hepatic fibrosis indexes(type IV collagen). | 24 weeks |
| The changes of hepatic fibrosis indexes(glycocholic acid.). | 24 weeks |
| Changes of visceral fat volume. | 24 weeks |
| Changes of subcutaneous fat volume. | 24 weeks |
| Changes of fasting blood glucose. | 24 weeks |
| Changes of fasting insulin. | 24 weeks |
| Changes of HbA1c. | 24 weeks |
| Changes of (HOMA-R). | 24 weeks |
| Blood lipid index(TC). | 24 weeks |
| Blood lipid index(TG). | 24 weeks |
| Blood lipid index(HDL-C). | 24 weeks |
| Blood lipid index(LDL-C). | 24 weeks |
| Changes of body weight. | 24 weeks |
| Changes of BMI. | 24 weeks |
| Changes of waist circumference. | 24 weeks |
| Changes of hip circumference. | 24 weeks |
| Changes of WHR. | 24 weeks |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |