Condition 1: Non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus. Condition 2: Type 2 diabetes mellitus. Fatty (change of) liver, not elsewhere classified Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The patient with type 2 diabetes mellitus Fasting blood sugar between 80 and 130 and HbA1C is less than 7% Age range 25 to 65 years Body mass index (BMI) ranges from 22 to 35 kg / m 2 The serum alanine transaminase level (ALT) is more than one and a half times higher than normal (ie, in men more than 45 and in women more than or equal to 29 units per liter according to the latest definition of abnormal ALT in men and women) Having a high-fatty liver disease (moderate to high) in liver ultrasound Conscious informed consent of patients to participate in the study
Exclusion criteria
Exclusion criteria: Pregnancy Liver failure (acute or chronic) Hepatitis such as autoimmune hepatitis, viral hepatitis B and C (active or inactive), Wilson's disease and ... Hypo and hyperthyroidism Renal failure (creatinin above 1.5 mg / dL) Diabetes-induced retinopathy Diabetic Nephropathy alcohol consumption Any malignancy (treated or not) Taking warfarin Taking contraceptives, ursodeoxycholic acid, glucocorticoids, statins, probiotics, vitamin E in the last three months History of allergy to ginger Addiction and drug abuse Heart disease History of allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver aminotrransferase (ALT) Level. Timepoint: Before intervention and three months after the intervention. Method of measurement: Colorimetric method.;Liver fibrosis. Timepoint: Before and three months after the intervention. Method of measurement: Fibrosan (ultrasound waves). | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Balance.;Body Mass Index (BMI). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Formula: Weight (Kg)/(Height)(m)2.;Abdominal circumference. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Tape measure.;Hip circumference. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Tape measure.;Insulin resistance index. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Homeostasis model assessment (HOMA-IR).;Glycosylated hemoglobin (HbA1C). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: HPLC.;Fasting Blood Sugar (FBS). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Enzymatic method.;Serum triglyceride (TG). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Enzymatic method.;Serum Cholesterol (Chol). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method.;Serum levels of aspartate aminotransferase (AST). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method.;Serum level of gamma glutamyltransp peptidase (GGT). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method.;Serum creatinine level. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Colorimetric method.;Tumor necrosis factor-alpha (TNF-a). Timepoint: Before the intervention and three months after the intervention began. Method of measurement: ELISA (Enzyme Linked | — |
Countries
Iran (Islamic Republic of)
Contacts
Shiraz University of Medical Sciences