Change in liver fat with Dapagliflozin treatment in Patients with Diabetes and Non-Alcoholic Fatty Liver Disease

Effect of Dapagliflozin on Liver and Body Fat and Insulin Resistance in Patients with Type-2 Diabetes and Non-Alcoholic Fatty Liver Disease - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079702

Enrollment

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Dapagliflozin: Tablet Dapagliflozin 10mg will be given to patients once daily for 6 months. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Patients will be included only if they satisfy all the 3 inclusion criteria : 1-Type 2 Diabetes Mellitus patients aged more than 18 years and duration of diabetes less than 5 years. 2-Blood Glycated hemoglobin A1c(HbA1c) levels between 6.5% to 10%, on a stable dose of metformin and/or sulfonylureas over last 8 weeks. 3-Grade II or greater Fatty infiltration on abdominal ultrasound.

Exclusion criteria

Exclusion criteria: 1.Type 2 Diabetes Mellitus patients with poor glycemic control (Blood Glycated hemoglobin(HbA1c) more than 10%) or repeated history of Diabetic Ketoacidosis or Hyperglycemic Hyperosmolar State. 2.Patients requiring insulin due to ppor glycemic control or any serious illness. 3.Patients needing any rescue oral hypoglycemic therapy, other than metformin, sulfonylureas and dapagliflozin to achieve glycemic targets as per American Diabetes Association Guidelines. 4.Pregnant women, lactating women, women planning for pregnancy and gestational diabetes 5.Patients with estimated Glomerular Filteration rate less than 30 ml/min 6.Alcohol consumption more than 20 g per day for women or 30 g per day for men 7.Serology positive for HbSAg, HCV infection. 8.Serum ferritin more than 300ng/ml 9.Serum Ceruloplasmin less than 14ng/ml 10.Serum ANA positivity 11.Child-Pugh class B/C liver cirrhosis 12.Confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E, UDCA)

Design outcomes

Primary

Measure	Time frame
1.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on liver fat signal fraction and fibrosis scores 2.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on body fat mass and anthropometric parameters 3.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on HOMA-IR and Adiponectin levels Timepoint: At baseline and at 6 months	—

Measure

Time frame

1.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on liver fat signal fraction and fibrosis scores 2.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on body fat mass and anthropometric parameters 3.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on HOMA-IR and Adiponectin levels Timepoint: At baseline and at 6 months

—

Secondary

Measure	Time frame
Effect of Dapagliflozin 10 mg in patients of Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease on HOMA-IR and serum Adiponectin levels Timepoint: 6 months	—

Countries

India

Contacts

Public ContactBandana Dash

MKCGMCH

doctorthesavior@gmail.com7008150945

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026