Study of the effect of ginger on biochemical markers and imaging of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus.

The perpose of this study is to evaluate the effects of ginger on biochemical parameters and imaging findings of non-alcoholic fatty liver in patients with type 2 diabetes.

This study is a randomized, double-blind, parallel clinical trial conducted on seventy non-alcoholic fatty liver disease in diabetic patients (type 2) who were referred to Shahid Motahari clinic in Shiraz in 1397.

The study population included 70 type 2 diabetic patients with non-alcoholic fatty liver disease referred to Shahid Motahari clinic (affiliated to Shiraz University of Medical Sciences).

Inclusion criteria: 1) Patients with controlled type 2 diabetes mellitus. 2) Fasting blood glucose is between 80 and 130 and HbA1C is less than 7%. 3) Age range 20 to 65 years 4) Body mass index (BMI) ranges from 18 to 35 kg/m2 5) 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) 6) Having fatty liver disease (moderate to high) in liver ultrasound 7) Informed consent to participate in the study Exclusion criteri: 1) Pregnancy 2) Liver failure (acute or chronic) 3) Liver diseases such as autoimmune hepatitis, viral hepatitis B and C (active or inactive), Wilson's disease and ... 4) Hypo and hyperthyroidism 5) Renal failure (creatinine above 1.5 mg / dL) 6) Diabetic retinopathy 7) Diabetic Nephropathy 8) alcohol consumption 9) Any malignancy (treated or not) 10) Taking warfarin 11) Taking contraceptives, ursodeoxycholic acid, glucocorticoids, statins, probiotics, vitamin E in the last three months 12) History of allergy to ginger 13) Heart disease 14) History of allergy

- Intervention group: Capsules containing ginger powder (500 mg) three times daily, half an hour after meal, for 3 months. - Placebo group (Control): Capsules (with the same shape, odor and color as intervention group) containing 500 mg of starch and ginger powder in a weight ratio of 1:10) three times daily, half an hour after meal, for 3 months. - All patients are advised to limit carbohydrate intake and daily physical activity for weight loss.

Weight and Body Mass Index (BMI), Abdominal circumference and hip circumference, Fasting Blood Glucose (FBS), Glycosylated hemoglobin (Hb-A1C), Serum triglyceride, serum cholesterol, Serum levels of alanine aminotransferase (ALT), serum levels of aspartate aminotransferase (AST), Gamma glutamyltransp peptidase (GGT), Tumor necrosis factor-alpha (TNF-α), C- Reactive Protein (CRP), Liver fibrosis and ultrasound findings, Insulin resistance index, serum creatinine.

Seventy diabetic patients with inclusion criteria who have fatty liver in ultrasound that graded based on the Saverymuttu Scoring System by a radiologist will enter the stydy. After justifying them to the study and obtaining written informed consent will be divided in two groups of 35 patients, A and B with use of random numbers.

Medication is made by a personal centre that has no relation with the patients and the research team and from the beginning, it is classified into two groups A and B with a completely similar appearance. The patients are also fully aware of the way the program is performed, but they do not know whether they are receiving the main medicine or the placebo. And the researcher who is related to the patients, as well as physicians who perform paraclinical and therapeutic procedures of the patients are not aware of which group of patients are in the intervention, as well as the collector information and data and statistics consultant are not aware of the content of these two groups.

Primary outcome measures

3 months after publication

People working in academic institutions

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Email: shams@sums.ac.ir

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