A comparative study of the use of metformin and ezetimibe compared to the use of metformin in the treatment of non-alcoholic fatty liver disease
- Conditions
- ?Diabetes.E11.6Type 2 diabetes mellitus with other specified complications
- Registration Number
- IRCT20090305001745N3
- Lead Sponsor
- Islamic Azad University of Shahrood
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Type 2 diabetes is known ( under treatment)
At least one year has passed since their diabetes
NAFLD grade 2 or 3 has been diagnosed by ultrasound
All patients should undergo non -pharmacological life style modification treatment
Newly diagnosed subjects
Type 1 diabetes
Receiving only insulin treatment
Drug intolerance disorders
Lack of consent to continue treatment
Diagnosis of type 1 NAFLD
Having a weight loss of more than 5 %
Having Infectious diseases , cancer, allergy and immune - based diseases
Smoking and alcohol consumption
Appetite disorders such as anorexia or overeating
Treatment with amphetamine, cyproheptadine, phenothiazine, appetite suppressants or appetite stimulants
Chronic viral hepatitis (HBV-HCV-HDV), drug-induced liver disease , Wilson's disease , hereditary deficiency of antitrypsin 1, idiopathic hemochromatosis, history of complications from liver diseases including ascites , encephalopathy or variceal bleeding
Uncontrolled cardiovascular or respiratory disease , active malignancy or active and chronic infections
The use of agents such as vitamin E- omega 3 fatty acids or drugs with evidence of their effect on NAFLD (pioglitazon , GLP 1analog , dipeptidyl peptidase inhibitors IV ,ursodeoxycholic acid)
Pregnancy or breastfeeding
Use of corticosteroids
Taking herbal medicines whose effect on fatty liver has been proven
Taking any nutritional supplements in the last 3 months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver steatosis. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Sonography.;Adiponectin gene expression. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Real time PCR.;PPAR- gama Gene expression. Timepoint: At the beginning of intervention and 6 months after that. Method of measurement: Real time PCR.;Activity of liver enzymes in serum. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Spectrophotometry.;Patients lipid profile. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Autoanalyzer (Spectrophotometry).;Serum Level of IL-6. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Enzyme Immunoassay.;Serum Level of Malone- di-aldehyde. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Spectrophotometry.
- Secondary Outcome Measures
Name Time Method Total Antioxidant Capacity. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Spectrophotometry.;Fasting blood glucose. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Autoanalyzer.;2 hours post prandial glucose. Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Autoanalyzer.;Glycated hemoglobin (HbA1c). Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Spectrophotometry.;Insulin Resistance Index ( HOMA-IR). Timepoint: At the beginning of intervention and 6 months after that date. Method of measurement: Calculation according to the related formula.