Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)
NCT ID: NCT05946148
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
78 participants
OBSERVATIONAL
2018-06-01
2021-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Empagliflozin group
Oral Empagliflozin 10mg daily, as add-on to their previous treatment regimen.
Empagliflozin
Empagliflozin 10mg daily, as add-on to previous treatment regimen.
Dulaglutide group
Subcutaneous Dulaglutide 1.5mg weekly, as add-on to their previous treatment regimen.
Dulaglutide
Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen
Control group
Optimal anti-diabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families), targeting glycemic control.
Control Rx
Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.
Interventions
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Empagliflozin
Empagliflozin 10mg daily, as add-on to previous treatment regimen.
Dulaglutide
Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen
Control Rx
Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
75 Years
ALL
No
Sponsors
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Alexandra Hospital, Athens, Greece
OTHER
Hippocration General Hospital
OTHER
National and Kapodistrian University of Athens
OTHER
Responsible Party
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KOULLIAS EMMANOUIL
INTERNIST
Principal Investigators
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JOHN KOSKINAS, PROFESSOR
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
ANASTASIA THANOPOULOU, AS PROFESSOR
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens
MELANIE DEUTSCH, AS PROFESSOR
Role: STUDY_CHAIR
National and Kapodistrian University of Athens
Locations
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"Hippocration" General Hospital of Athens
Athens, Attica, Greece
Countries
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Other Identifiers
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SC12/16-6-2016
Identifier Type: -
Identifier Source: org_study_id
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