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Evaluation of the effects of Dapaglifozin on liver on patients with Type 2 Diabetes Mellitus and Metabolic liver disease

Evaluation of the Effects of Dapaglifozin (sglt-2 inhibitor) on Hepatic Steatosis and fibrosis using Anthropometric, Biochemical and Radiological indices in patients with type 2 Diabetes Mellitus and Non Alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050799
Enrollment
71
Registered
2023-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

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

Interventions

Intervention1: DAPAGLIFOZIN: Sodium-glucose cotransporter-2 (SGLT2) inhibitor Intervention2: Dapaglifozin: Sodium-glucose cotransporter-2 (SGLT2) inhibitor 10 mg once daily for 24 weeks Control Interv

Sponsors

Department of medicine Jawaharlal Nehru medical college and hospital AMU Aligarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed type 2 DM patients on standard treatment for diabetes whether be it Insulin or oral hypoglycemic agents except all SGLT2 Inhibitors 2. Patients diagnosed with NAFLD made on the basis of history of low daily alcohol intake ( 3. Patients giving informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with other causes of chronic liver disease like chronic viral hepatitis, autoimmune hepatitis, excessive alcoholic consumption, drug-induced liver injury, biliary tract disease, decompensated liver cirrhosis, hepatocellular carcinoma, history of diabetic ketoacidosis 2. Patients with co-administration of medications that may affect liver function tests (such as NSAIDS, Vitamin E, pioglitazone, saroglitazar, statin, and TZDs) 3. Presence of severe comorbidities such as CAD, CHF, CKD, COPD, pyelonephritis and chronic UTI

Design outcomes

Primary

MeasureTime frame
The key primary endpoint is the change in LS (liver stiffness) from baseline to 24 weeks of treatmentTimepoint: At baseline and at 24 weeks—

Secondary

MeasureTime frame
Change in HbA1c, liver enzymes (AST, ALT, and GGT), Anthropometric markers (BMI, Waist circumference, subcutaneous adipose tissue) and various markers and scores (FIB-4 Index, NAFLD Score, aspartate aminotransferase to platelet ratio index (APRI)) for hepatic fibrosis from baseline to 24 weeks of treatment.Timepoint: 24 weeks—

Countries

India

Contacts

Public ContactDr Husaini S Haider Mehdi

Jawaharlal Nehru medical college and hospital , Aligarh Muslim University

dr.haiderhusaini2k@gmail.com8958786889

Outcome results

None listed

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