IRCT20190122042450N3
Completed
Phase 2
Comparison of the effect of empagliflozin and pioglitazone and placebo on liver steatosis change in fibroscan in diabetic patients with non-alcoholic fatty liver disease
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Iran University of Medical Sciences
- Enrollment
- 105
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index less than 40
- •Alcohol daily consumption less than 20 g in women and less than 30 g in men, for at least 3 consecutive months over 5 years ago
- •Hemoglobin A1c 7\-10 percent
- •Alanin aminotransferase more than 45 in men and more than 30 in women
- •Creatinin less than 1\.5 in men and less than 1\.4 in women and glomerular filtration rate more than 45
- •Controlled atenuated parameter more than 230 in fibroscan or fatty liver grade equal and more than 2 in liver sonography
- •Signature of consent form
Exclusion Criteria
- •Pregnancy, breast feeding
- •Heart failure (class II to IV)
- •History of cardiovascular disease in 3 months ago
- •History of cancer in 2 years ago
- •History of cirrhosis Abnormal TSH (uncontrolled yper or hypothyroidism)
- •Autoimmune hepatitis (abnormal ANA and ASMA)
- •Hepatitis C (positive HCV Ab)
- •Hepatitis B (positive HBS Ag)
- •Consumption of NSAIDs, Amiodarone, Tamoxifen, Fibrate, statin, Zinc, Selenium and vitamin C or other antioxidant drugs, Empagliflozin, Metformin, Pioglitazone, Vitamin E and other fatty liver drugs.
- •Diabetes type 1 or secondary diabetes
Outcomes
Primary Outcomes
Not specified
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