Dapagliflozin is a licensed medicine used for reducing blood sugar in people with diabetes and this study will test whether it can also reduce the stiffness in the liver which commonly occurs in diabetes.

Not Applicable

Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Registration Number: CTRI/2019/05/019286

Lead Sponsor: Dr Shashi Panicker

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subjects who are willing and given their informed consent prior to any study-specific prodedures.

2.Female or male aged 30 years or more

3. Recently diagnosed or known cases of type 2 diabetes

4.HbA1c above 7%

5.Presence of NASH

6.Fulfilment of criteria for non-alcoholic fatty liver disease

7.eGFR >45/ml/1.73m squared

Exclusion Criteria

1.Diagnosis of Type 1 Diabetes

2.History of Bladder cancer

3.History of radiation therapy to the lower abdomen or pelvis at any time

4.Chronic cystitis and/ or recurrent urinary tract infections

5.Pregnant or breastfeeding women

6.Subjects with cirrhosis of the liver or obstructive biliary disease will be excluded.

7.Chronic Hepatitis B and hepatitis C

8.Subjects with alpha-1 antitrypsin deficiency and Wilsonâ??s disease will be excluded.

9.Patients on Tamoxifen, methotrexate, amiodarone, thiazolidinediones, incretin mimetics like liraglutide and DPP4 inhibitors, or SGLT2 inhibitors like dapagliflozin, canagliflozin, or empagliflozin, will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether dapagliflozin significantly reduces the degree of steatohepatitis in patients of type 2 diabetes with NASHTimepoint: 200 days

Secondary Outcome Measures

Name	Time	Method
Effects of dapagliflozin on: <br/ ><br>Obesity indices: Body weight, BMI, Waist circumference, Waist-Height Ratio, Visceral fat, Body fat <br/ ><br>Lipid profile <br/ ><br>Micro- or macroalbuminuria <br/ ><br>HbA1c <br/ ><br>Liver enzymes <br/ ><br>Serum Albumin <br/ ><br>Insulin resistance <br/ ><br>Urinary Albumin-creatinine ratio <br/ ><br>Pulse Wave Velocity for Arterial stiffness <br/ ><br>Liver functions <br/ ><br>Hepatic scores: NAFLD fibrosis score, FIB4 Score <br/ ><br>Platelet count, PCT, MPV <br/ ><br>Quality of Life Measurements <br/ ><br>Timepoint: 200 days;Resolution of NASH if liver stiffness measurement is less than 6 kPaTimepoint: 200 days