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

NCT05946148 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2023-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Liver Steatosis

Interventions

DRUG

Empagliflozin

Empagliflozin 10mg daily, as add-on to previous treatment regimen.

DRUG

Dulaglutide

Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen

DRUG

Control Rx

Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.

Sponsors & Collaborators

  • Alexandra Hospital, Athens, Greece

    collaborator OTHER

  • Hippocration General Hospital

    collaborator OTHER

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • JOHN KOSKINAS, PROFESSOR · National and Kapodistrian University of Athens

  • ANASTASIA THANOPOULOU, AS PROFESSOR · National and Kapodistrian University of Athens

  • MELANIE DEUTSCH, AS PROFESSOR · National and Kapodistrian University of Athens

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Drug
Yes

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946148 on ClinicalTrials.gov