Evaluating the effect of Dapagliflozin on Alanine Transaminase Levels in Type 2 Diabetic Patients with Non Alcoholic Fatty Liver Disease

Phase 4

• Conditions: on Alcoholic Steatohepatitis; Type 2 Diabetes Mellitus; Non Alcoholic Steatohepatitis; Metabolic and Endocrine - Diabetes; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000039583
• Lead Sponsor: MTI Lady Reading Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-17
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Age 16 years or older.
2.Gender: Any
3.Patients already diagnosed as having type 2 diabetes mellitus (Fasting blood glucose of >126 mg/dl or HbA1C > 6.5 %) , having suboptimal glycemic control (HbA1C > 7%) on current treatment who are having Alanine Transaminase (ALT)levels > 40IU/L and ultrasonographical features of Non Alcoholic Fatty Liver Disease (NAFLD).

Exclusion Criteria

1.Patients with type 1 diabetes mellitus (Sodium-Glucose Co Transporter 2 (SGLT2) inhibitors (SGLT2 inhibitors may precipitate Diabetic Ketoacidosis)

2. Pregnancy (SGLT2 inhibitors not licensed).

3.Patients already on SGLT2 inhibitors

4.Patients having impaired renal function (estimated Glomerular Filtration rate of < 45ml/min/1.73m2),

5.Patients having chronic liver disease, positive viral serology for hepatitis B and C, history of alcohol consumption, having clinical features of hyperthyroidism, recent infections, history of cancer and evidence of gall-stones/cholecystitis on ultrasound,

6.Patients having recent (within 6 months) acute coronary syndrome

7. Cancer of any sort.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Alanine Transaminase(ALT) level using ALT blood test.[ Baseline and 12 weeks post commencement of intervention.]

Secondary Outcome Measures

Name	Time	Method
Glycated Hemoglobin HbA1C levels using Hemoglobin A1C (HbA1C) blood test.[ Baseline and 12 weeks post commencement of intervention.];Change in Weight in kilograms checked in clinic on a digital scale. [ Baseline and 12 weeks post commencement of intervention.];Urinary tract infections by urine dipstick test.[ Baseline and 12 weeks post commencement of intervention.];Genital Mycotic infections by history suggesting these infections and clinical examination.[ Baseline by history, between baseline and and 12 weeks post commencement of intervention by history and clinical examination if symptomatic, and 12 weeks post commencement of intervention by history alone.]