IRCT20220115053717N1
Completed
Phase 2
The comparison of the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens
Oroumia University of Medical Sciences0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 2 diabetic patients with nonalcoholic fatty liver disease.
- Sponsor
- Oroumia University of Medical Sciences
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Controlled type 2 Diabetes Mellitus (T2DM) with HbA1C\=6\.5\-10
- •BMI greater than 20, with the last 3 months loss of weight below 10%
- •treatment with Metformin, 1500mg daily, at least 3 months as monotherapy
- •Statin consumption
- •Definitive diagnosis of NAFLD under the supervision of a Gastroenterology subspecialty
- •at least grade 1 of non\-alcoholic fatty liver disease (NAFLD) based on ultrasonography
Exclusion Criteria
- •Type 1 Diabetes Mellitus (T1DM)
- •Treated with other diabetes medications except for metformin at baseline
- •History of pancreatitis or pancreas related diseases
- •At the beginning of the study ALT more than twice normal upper limits
- •eGFR lower than 45 ml/min
- •Decompensated or untreated Heart Failure (functional class 3 or 4\)
- •Other liver diseases include autoimmune hepatitis and viral hepatitis
- •Alcohol consumption more than 140 cc for women and 250 cc for men per week
- •A pregnant woman or someone who is planning a pregnancy
- •breastfeeding
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
The cardiac effect of pioglitazone and empagliflozin among diabetic patients with NAFLDCondition 1: Nonalcoholic fatty liver disease. Condition 2: Type 2 Diabetes. Condition 3: Cardiomyopathy.Nonalcoholic steatohepatitis (NASH)Type 2 diabetesCardiomyopathyK75.81IRCT20190122042450N5Iran University of Medical Sciences70
Recruiting
Phase 3
Effect of Empagliflozin in PrediabetesCondition 1: Impaired fasting glucose. Condition 2: Impaired glucose tolerance.Impaired fasting glucoseImpaired glucose tolerance (oral)R73.01R73.02IRCT20220902055858N1Shahre-kord University of Medical Sciences90
Completed
Phase 2
The effect of empagliflozin on nonalcoholic fatty liver disease in diabetic patientsIRCT20190122042450N3Iran University of Medical Sciences105
Completed
Phase 3
Comparing the effect of Empagliflozin with Pioglitazone on nonalcoholic fatty liverIRCT20220928056051N1Oroumia University of Medical Sciences60
Not yet recruiting
Phase 2
The effect of Empagliflozin on nonalcoholic fatty liver disease in non-diabetic patientson alcoholic fatty liver disease.Nonalcoholic steatohepatitis [NASH]K75.81IRCT20190122042450N1Iran University of Medical Sciences100