The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus

Korábbi kezelés

• Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids)
• Treatment with vitamin E during the previous 3 months.
• Contraindications to SGLT2-I use (history of acute or chronic pancreatitis or pancreatic cancer, or history of recurrent urinary tract or genital infections, current or previous gangrene).
• History of bariatric surgery or ongoing weight-loss diet (hypocaloric diet) or use of weight-loss agents unless the diet or treatment has been stopped at least 3 months before screening and that the patient has had a stable body weight (+/- 3 kg) during the 3 months before screening.
• Drug abuse or alcohol abuse.
• Any blood donation/blood loss >500 ml during the 3 months prior to Visit 1 or during the study.
• Patient use of anti-inflammatory medications or corticosteroids during the observational period

Más betegség

• Diagnosis or signs of type 1 diabetes or non-diabetic patients
• Other causes of chronic hepatic steatosis (e.g., Hepatitis B virus ,Hepatitis c virus, autoimmune disease, Wilson disease, drugs, alpha one antitrypsin deficiency).
• Patients with diagnosis of or clinical features that are suspected for another systemic disease that commonly causes liver disease.
• Patient with history of liver transplantation
• Positive HIV test
• Intolerance or allergy SGLT2-I or any other substance in the tablets.
• History of or presence of (as found at Visit 1) any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
• Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the investigator. This includes signs of liver disease other than non-alcoholic fatty liver disease that motivated further investigations or treatment based on clinical judgment.
• Any other condition the investigator believed would interfere with the patient's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
• Patients with active malignancy
• Patients with established hemolytic disease
• The patient will be excluded from the study after the randomization if the second compound of combination therapy is inconsistent with the standard of medical care in diabetes -2022.

Laborértékek

• Highly uncontrolled diabetes (HbA1c >86 mmol/mol [>10.0%])
• Treatment with glucose-lowering drugs that influence liver fat, including thiazolidinediones, α-glucosidase inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors or any glucagon-like peptide-1 receptor agonists during the previous 3 months.
• Creatinine clearance <90 ml/min at screening (Cockcroft-Gault formula).
• Severe hepatic injury and/or significant abnormal liver function defined as aspartate aminotransferase >5× upper limit of normal (ULN) and/or alanine aminotransferase >5× ULN.
• Total bilirubin >2.0 mg/dl (34.2 μmol/l)\

Egyéb

• BMI ≥40 kg/m2
• Detection of biliary duct obstruction based on imaging studies.
• Evidence of cirrhosis (on basis of ultrasonography and MRI) or hepatocellular carcinoma (evidence on triphasic CT or MRI).
• Women who are pregnant, lactating or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Acceptable contraceptive methods will be combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomized.
• Refused to consent to this study.
• Missing the follow up.

• Men or women aged ≥20 years old who will be:
  • Diagnosed with type 2 diabetes since ≥6 months in accordance with World Health Organization criteria (22); and
  • Present with glycated hemoglobin equal to or greater than 7% and less than 10% after at least three months of treatment with metformin monotherapy at the maximal tolerated dosage or sulfonylurea alone or in combination; and
  • Diagnosed with Metabolic associated steatotic liver disease