?Diabetes. Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention 1: Intervention group: grade 2 non- alcoholic fatty liver patients with diabetes receives a daily dose of 10 mg ezetimibe (Hakim pharmaceutical company )and between 500-2500 mg metformin
Sponsors
Islamic Azad University of Shahrood
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Taghi Goodarzi
Islamic Azad University of Shahrood
Outcome results
None listed