Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

Launched by ZHUJIANG HOSPITAL · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Henagliflozein on liver fat levels in patients who have both type 2 diabetes and nonalcoholic fatty liver disease. The goal is to see if this treatment can help reduce fat in the liver over a 24-week period. Participants will be randomly assigned to either receive Henagliflozein along with metformin—another diabetes medication—or a different combination of medications that includes Linagliptin and metformin. Throughout the study, healthcare professionals will monitor participants’ progress and provide guidance on diet and exercise.

To be eligible for this trial, participants should be diagnosed with type 2 diabetes within the last five years and have nonalcoholic fatty liver disease. They should also be managing their diabetes with diet, exercise, or specific medications. The study is looking for individuals aged 18 and older who are willing to commit to the full 24 weeks and follow the trial requirements. Participants can expect regular check-ins at 8, 16, and 24 weeks to track their health, and they will receive support from nutritionists to help with lifestyle changes during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019)
• • 2. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)
• • 3. Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions.
• • 4. HbA1c: 7.0%-8.5%
• • 5. Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010)
• Exclusion Criteria:
• • 1. Patients with type 1 diabetes, gestational diabetes or other special types of diabetes;
• • 2. Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and / or diastolic blood pressure (DBP) ≥ 100mmHg;
• • 3. Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism;
• • 4. Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment；
• • 5. Have a history of severe infection, trauma or major surgery within 3 months;
• • 6. Have a history of drug abuse with 5 years, including repeated use of dependence-producing drug unrelated to medical purposes, including addictive and habitual drugs leading to physical and psychic dependence;
• • 7. Have a history of participating any intervention drug or instrumental clinical trial 3 months before screening;
• • 8. Have a history of severe anemia or need regular blood transfusion treatment;
• 9. Have a history of any medication or treatment below:
• (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:
• • 1. AlanineAminotransferase(ALT)and/oraspartateaminotransferase(AST) higher than 5 times of the upper limit of the normal value.
• • 2. Glomerular Filtration Rate (eGFR) estimated by CKD-EPI formula \< 40mL/ (min·1.73m2); 11.Patients are currently pregnant, breastfeeding or planning a pregnancy; 12.Have a history of infectious diseases such as hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), pulmonary tuberculosis or sexually transmitted active diseases such as HIV and syphilis; 13.Have a history of using anti-NASH drugs (vitamin E, ursodeoxycholic acid, s-Adenosylmethionine, betaine, silymarin, gemdibrozil, anti-TNF therapy, probiotics, ect.) within 3 months before random grouping; 14.Having structural and functional genitourinary abnormalities prone to cause genitourinary infection; 15.Patients with abnormal hematologic system or any diseases that may cause hemolysis or unstable erythrocyte; 16.Have a history of using immunomodulators, such as biological agents, cyclophosphamide, cyclosporine, etc.; 17.Patients with MRI incompatible metal or magnetic implant, device or materials.