the Effect of Stevia Dry Leaves on Serum Levels of Liver Enzymes, Lipid Profile, Glycemic Indicators, Adiponectin and Leptin in Overweight and Obese Diabetic Patients with Non-Alcoholic Fatty Liver

the Effect of Stevia Dry Leaves on Serum Levels of Liver Enzymes, Lipid Profile, Glycemic Indicators, Adiponectin and Leptin in Overweight and Obese Diabetic Patients with Non-Alcoholic Fatty Liver

The present study is a Phase 3 clinical trial, double-blind, and parallel, on 50 diabetic patients with overweight and obese fatty liver who have criteria for entering the study. The random numbers table is divided into two groups of intervention and control and each person is assigned a code.

This study was performed on diabetic patients with overweight and obesity and fatty liver, referred to Soroush specialized clinic in Ahvaz, Khuzestan province. At the beginning and the end of the study, fasting blood samples will be taken to evaluate lipid, glycemic, leptin, and adiponectin profiles. Physical diet and physical activity will be recorded by dietary intake and physical activity questionnaire.

Inclusion criteria: Overweight and obese diabetic patients with non-alcoholic fatty liver (Grade 1, 2 and 3) having an ultrasound sheet with a non-alcoholic fatty liver diagnosis with a approved gastroenterologist in the range of 20 to 60 years of ageradiologist and an Non-inclusion criteria: pregnancy and lactation؛ liver transplantation; hereditary hematocromatosis and Wilson; positive test for hepatitis C, B and autoimmune hepatitis

Intervention group: 2 capsules of 250 mg of stevia dry leaves for 8 weeks Control group: 2 capsules of 250 mg starch per day for 8 weeks

Fasting Glucose; Insulin; Insulin Resistance; Lipid Profile; Leptin ; Serum Adiponectin; and Liver Enzymes

Simple randomization، Use random numbers Table

The type of blindness in our study will be double-blind. Prior to the onset of the study, the box containing the relevant pills are coded A and B by an individual except the researcher, in order to blind the researcher about which supplement each group received. When delivering supplements to patients, some one except the researcher should locate the patient in either A or B group by random number table. In this study, the patients and researcher (who collecting data, assessing the outcome and analyzing the data) should be kept blind.