Overview
The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-10-01
2024-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Study question 1:Could SGLT2-I improve hepatic fibrosis, steatosis, and inflammatory markers in type 2 diabetic patients with Metabolic associated steatotic liver disease Question 2:Which drug of SGLT2-I group is more effective in improving metabolic associated steatotic liver disease in type 2 diabetic patients?Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sohag UniversityTreatments:
Dapagliflozin
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Criteria
Inclusion Criteria:- Men or women aged ≥20 years old who will be:
1. Diagnosed with type 2 diabetes since ≥6 months in accordance with World Health
Organization criteria (22); and
2. 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
3. Diagnosed with Metabolic associated steatotic liver disease
Exclusion Criteria:
- Diagnosis or signs of type 1 diabetes or non-diabetic patients
- Highly uncontrolled diabetes (HbA1c >86 mmol/mol [>10.0%])
- BMI ≥40 kg/m2
- Other causes of chronic hepatic steatosis (e.g., Hepatitis B virus ,Hepatitis c virus,
autoimmune disease, Wilson disease, drugs, alpha one antitrypsin deficiency).
- Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate,
tamoxifen, methotrexate, steroids)
- 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.
- Detection of biliary duct obstruction based on imaging studies.
- 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
- Evidence of cirrhosis (on basis of ultrasonography and MRI) or hepatocellular
carcinoma (evidence on triphasic CT or MRI).
- Positive HIV test
- Treatment with vitamin E during the previous 3 months.
- Intolerance or allergy SGLT2-I or any other substance in the tablets.
- 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 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.
- 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)\
- 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.
- 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.
- Drug abuse or alcohol abuse.
- 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.
- 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.
- Any blood donation/blood loss >500 ml during the 3 months prior to Visit 1 or during
the study.
- Patients with active malignancy
- Patients with established hemolytic disease
- Refused to consent to this study.
- 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.
- Patient use of anti-inflammatory medications or corticosteroids during the
observational period
- Missing the follow up.