The cardiac effect of pioglitazone and empagliflozin among diabetic patients with NAFLD

Phase 2

Recruiting

• Conditions: Condition 1: Nonalcoholic fatty liver disease. Condition 2: Type 2 Diabetes. Condition 3: Cardiomyopathy.; Nonalcoholic steatohepatitis (NASH); Type 2 diabetes; Cardiomyopathy; K75.81

• Registration Number: IRCT20190122042450N5
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Type 2 diabetes mellitus (T2DM)
HbA1C between 7-10.5%
Non-alcoholic fatty liver disease (NAFLD) with cap score >302 dB/m
Normal Ejection Fraction (EF=50%)

Exclusion Criteria

??Arrhythmia
Ischemic or non Ischemic heart disease
Peripheral artery disease
Current use of SGLT2 inhibitors
Current use of Glucagone like peptide 1 receptor agonist
Current use of Thiazolidendions
Current use of Tamoxifen
Current use of Amiodarone
Current use of Nonsteroid anti inflammatory agents
Current use of Vitamin C
Current use of Vitamin E
Current use of Selenium
Current use of other antioxidants
Pregnancy
Breast feeding
Hypothyroidism
Hyperthyroidism
Cirrhosis
Hepatitis B
Hepatitis C
Autoimmune Hepatitis
Any form of chronic liver disease except fatty liver disease
Alcohol consumption more than 30 gr/day in men
Alcohol consumption more than 20 gr/day in women
eGFR<45 cc/min/1.73 m2
Corticosteroid use at least 14 days in the past month
Active cancer
History of the treated cancer in the past 2 years.
Current use of fibrates

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiographic Indices. Timepoint: At screening time (visit 1) and 24 weeks after the start of treatment (visit 7). Method of measurement: Echocardiograghy.

Secondary Outcome Measures

Name	Time	Method
Weight. Timepoint: At start ,after 12 weeks and 24 weeks. Method of measurement: weight scale.;Body mass index (BMI). Timepoint: At start ,after 12 weeks and 24 weeks. Method of measurement: Calculation with formula.;Liver stiffness measurement (LSM). Timepoint: At start and 24 weeks after intervention. Method of measurement: Liver fibroscan.;Nonalcoholic fatty liver disease fibrosis score. Timepoint: At start and 24 weeks after intervention. Method of measurement: By use of labroatary tests and formula of the NAFLD fibrosis score.;FIB4 index. Timepoint: At start and 24 weeks after intervention. Method of measurement: By use of laboratory tests and formula of the FIB4.;The change of CAP (Controlled attenuation parameter). Timepoint: At start and 24 weeks. Method of measurement: By liver fibroscan.