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

First listed
Jul 14, 2023
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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