Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946148
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2023-07-05
Brief Title:
Novel Antidiabetic Medications and Their Effect on Liver Steatosis NAMELS-18
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
Effect of Dulaglutide vs Empagliflozin on Non-alcoholic Fatty Liver Disease of Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAMELS-18
Brief 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
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
Detailed Description:
Rationale
NAFLD is the most common chronic liver disease worldwide Presently relative clinical guidelines focus on weight loss through apporopriate diet and lifestyle The Glucagon-Like Peptide 1 receptor agonists and the Sodium-Glucose Co-transporter 2 inhibitors constitute novel agents that seem to exert beneficial effects beyond glycemic control Dulaglutide will be used from the GLP1-ras family and Empagliflozin from the SGLT2-is family
Research question
Is the use of Empagliflozin or Dulaglutide effective in improving liver fat fraction in patients with type 2 diabetes mellitus and NAFLD Which is more beneficial
Hypothesis
The investigators hypothesize that both Dulaglutide and Empagliflozin have a role in treating patients with DM2 and NAFLD
Aim of the study
To compare the effect of Dulaglutide and Empagliflozin in liver fat fraction of diabetic patients after a year of treatment
Objectives
Assess liver steatosis change in patients Determine percentage of those with 30 liver fat concentration reduction
Compare Empagliflozin group with Dulaglutide group and Control group Evaluate the impact of the medications used on glycemic control weight loss liver enzymes lipids and 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
Material and methods
Site of study
This study will be conducted in the 2nd Department of Internal Medicine of Hippocration General Hospital and the Therapeutic Department of General Hospital Alexandra Athens Greece
Type of study
This is a prospective open-label observational study
Subjects allocation
Group 1 patients will receive oral Empagliflozin as add-on to their previous treatment regimen for 52 weeks
Group 2 patients will receive subcutaneous Dulaglutide as add-on to their previous treatment regimen for 52 weeks
Group 3 patients will receive other optimal antidiabetic treatment apart from agents of the GLP1-ras or SGLT2-is families for 52 weeks
Patients receiving Pioglitazone were not included in the study
Steps of performance and techniques
Medical history and complete physical examination Informed consent Calculation of BMI measurement of waist and hip circumference Blood tests including Liver function tests Complete blood count Urea and Creatinine Lipid profile total cholesterol triglycerides LDL HDL fasting plasma glucose and HbA1c
Abdominal ultrasound Magnetic Resonance Imaging-Proton Density Fat Fraction Shearwave Elastography
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
Assessment of changes between date of entry in the study and 52 weeks of treatment
NAFLD is the most common chronic liver disease worldwide Presently relative clinical guidelines focus on weight loss through apporopriate diet and lifestyle The Glucagon-Like Peptide 1 receptor agonists and the Sodium-Glucose Co-transporter 2 inhibitors constitute novel agents that seem to exert beneficial effects beyond glycemic control Dulaglutide will be used from the GLP1-ras family and Empagliflozin from the SGLT2-is family
Research question
Is the use of Empagliflozin or Dulaglutide effective in improving liver fat fraction in patients with type 2 diabetes mellitus and NAFLD Which is more beneficial
Hypothesis
The investigators hypothesize that both Dulaglutide and Empagliflozin have a role in treating patients with DM2 and NAFLD
Aim of the study
To compare the effect of Dulaglutide and Empagliflozin in liver fat fraction of diabetic patients after a year of treatment
Objectives
Assess liver steatosis change in patients Determine percentage of those with 30 liver fat concentration reduction
Compare Empagliflozin group with Dulaglutide group and Control group Evaluate the impact of the medications used on glycemic control weight loss liver enzymes lipids and 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
Material and methods
Site of study
This study will be conducted in the 2nd Department of Internal Medicine of Hippocration General Hospital and the Therapeutic Department of General Hospital Alexandra Athens Greece
Type of study
This is a prospective open-label observational study
Subjects allocation
Group 1 patients will receive oral Empagliflozin as add-on to their previous treatment regimen for 52 weeks
Group 2 patients will receive subcutaneous Dulaglutide as add-on to their previous treatment regimen for 52 weeks
Group 3 patients will receive other optimal antidiabetic treatment apart from agents of the GLP1-ras or SGLT2-is families for 52 weeks
Patients receiving Pioglitazone were not included in the study
Steps of performance and techniques
Medical history and complete physical examination Informed consent Calculation of BMI measurement of waist and hip circumference Blood tests including Liver function tests Complete blood count Urea and Creatinine Lipid profile total cholesterol triglycerides LDL HDL fasting plasma glucose and HbA1c
Abdominal ultrasound Magnetic Resonance Imaging-Proton Density Fat Fraction Shearwave Elastography
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
Assessment of changes between date of entry in the study and 52 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None