The effect of ertugliflozin in patients with nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus.

The total number of participants will be randomized into 3 groups. The 1:1:1 allocation sequence will be used for dug administration. The first group will take Ertugliflozin 15 mg oral tablet once daily for 6 months. The second group will take a control drug Pioglitazone oral tablet once daily for 6 months while the third group will receive a placebo (starch tablets) orally once daily for 6 months. The drug is given to patients with a regular diet. The side effects were explained in detail. The monitoring of possible side effects will be determined through information given by participants or self reporting method. The intervention will be continued for 24 weeks (6 months). The baseline of all biochemical parameter will be measured and recorded in each patient record. At 12th week (3 months) the baseline of all biomarker will be measured in order to asses any improvement in fatty liver grading, liver enzyme and quality of life. The adherence strategies involve the counting of pills returned by participant. Self-monitoring of blood sugar was done by patients to monitor blood sugar fluctuations and HbA1c was also monitored in the mid of the observation period to maintain glycemic targets. The frequency of patient visits was individualized as per the blood glucose levels. The total interventional period is 6-8 months. Other necessary investigations were done during the observation period on the required basis to prevent any complications or side effects and to monitor the rapid deterioration of liver functions. The data will be compared to the placebo as well as to the control. The difference will be measured and recorded along with all biomarkers data.