Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)

Sponsor
National and Kapodistrian University of Athens
Study ID
NCT05946148
Status
Completed

Conditions

  • Liver Steatosis
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin 10mg daily, as add-on to previous treatment regimen.
  • Dulaglutide — DRUG
    Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen
  • Control Rx — DRUG
    Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.

Study Details

The goal of this clinical study is to compare the therapeutic effect of Dulaglutide and Empagliflozin in patients with Diabetes Mellitus type 2 and Non-Alcoholic Fatty Liver Disease. The main question it aims to answer is: Is there a beneficial effect regarding liver steatosis in patients receiving either of these 2 medications and which is more effective? Patients will undergo shearwave elastography, magnetic resonance imaging, and ultrasound. Furthermore, calculation of the Fatty Liver Index (FLI), the Fibrosis-4 Index (FIB-4), as well as the Aspartate Aminotransferase to Platelet ratio Index (APRI) and the NAFLD Fibrosis Score (NFS) will be performed. Researchers will compare 3 groups: Group 1 will receive oral Empagliflozin, as add-on to their previous treatment regimen, for 52 weeks. Group 2 will receive subcutaneous Dulaglutide, as add-on to their previous treatment regimen, for 52 weeks. Group 3 will receive other optimal antidiabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families) for 52 weeks.

Key Dates

Start date
Jun 1, 2018
Status verified
Jul 2023
Primary completion
May 31, 2021
Completion
May 31, 2021

Study Design

Enrollment
78 participants (actual)

Arms

  • Arm: Empagliflozin group
    Oral Empagliflozin 10mg daily, as add-on to their previous treatment regimen.
  • Arm: Dulaglutide group
    Subcutaneous Dulaglutide 1.5mg weekly, as add-on to their previous treatment regimen.
  • Arm: Control group
    Optimal anti-diabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families), targeting glycemic control.

Primary Outcome Measure

Liver Fat Fraction reduction [ Time Frame: 52 weeks ]

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