Non-alcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: In group one, patients will receive 30 mg pioglitazone daily in addition to the standard treatment (metformin) for 6 months. Intervention 2: Intervention group: in
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 20 to 75 years Type 2 diabetes A hemoglobin A1C (HbA1c) between 7 and 10 Body mass index (BMI) between 20 to 40 kg/m2 Treated with metformin for at least three months with a minimum dose of 1500 mg daily ?At least grade 1 of non-alcoholic fatty liver disease (NAFLD)
Exclusion criteria
Exclusion criteria: Patients receiving drugs that stimulate insulin secretion, or insulin Type 1 diabetes Patients treated with diabetes drugs including sitagliptin and liraglutide Glomerular Filtration Rate (GFR) less than 30 Uncontrolled or aggravated heart disease (class 3 and 4) Liver diseases including autoimmune hepatitis and viral hepatitis Alcohol consumption of more than 140 cc for women and 250 cc for men per week Pregnancy breastfeeding History of recurrent urinary tract infection Bladder Cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver steatosis score. Timepoint: Before and 6 months after the intervention. Method of measurement: Fibroscan.;Alanine transaminase (ALT). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample.;Aspartate transaminase (AST). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample.;Alkaline phosphatase (ALKP). Timepoint: Before and 6 months after the intervention. Method of measurement: blood sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA?c. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Cholesterol. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;High-density lipoprotein (HDL). Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Low-density lipoprotein (LDL). Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Triglyceride. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Serum creatinine. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample.;Glomerular filtration rate (GFR). Timepoint: Before and 6 months after the intervention. Method of measurement: Based on the formula.;Serum insulin. Timepoint: Before and 6 months after the intervention. Method of measurement: Blood sample. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Laya Hooshmand
Oroumia University of Medical Sciences
Outcome results
None listed