Non-Alcoholic Fatty Liver DiseaseNAMELS-18NCT05946148
Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)
An observational study of Non-Alcoholic Fatty Liver Disease and Liver Steatosis, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Liver Steatosis
- What is being tested?
- Empagliflozin and Dulaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2018to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caucasian, 25-75 years old, diagnosed with type 2 diabetes mellitus and fatty liver.
Who may be able to join
- Presence of diabetes mellitus type 2 and non-alcoholic fatty liver Stable anti-diabetic treatment regimen for the past 6 months
Who cannot join
- Recent (last 5 years) medical history of cancer, pancreatitis, viral hepatitis or any other cause of liver disease (alcohol abuse, autoimmune hepatitis, hemochromatosis, heart failure etc.) Recent alteration (<6 months) of anti-diabetic regimen. Already established treatment with GLP1-ras or SGLT2-is prior to screening. Treatment with Pioglitazone. Corticotherapy administration. Pregnant or planning for pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dulaglutide vs Empagliflozin on Non-alcoholic Fatty Liver Disease of Patients With Type 2 Diabetes Mellitus
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:
Read more
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Liver Steatosis
- Being tested
- Empagliflozin, Dulaglutide, Control Rx
- Keywords
- Empagliflozin, Dulaglutide, Liver Steatosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called E
Empagliflozin 10mg daily, as add-on to previous treatment regimen.
DulaglutideDrug
Also called D
Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen
Control RxDrug
Also called C
Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin group | Oral Empagliflozin 10mg daily, as add-on to their previous treatment regimen. Receives: Drug: Empagliflozin | |
| Dulaglutide group | Subcutaneous Dulaglutide 1.5mg weekly, as add-on to their previous treatment regimen. Receives: Drug: Dulaglutide | |
| Control group | Optimal anti-diabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families), targeting glycemic control. Receives: Drug: Control Rx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Fat Fraction reduction
Change of Liver Fat Fraction as calculated by MRI-PDFF
Measured: 52 weeks
>30% Liver Fat Fraction reduction
Percentage of each group's participants that achieves >30% Liver Fat Fraction reduction
Measured: 52 weeks
Secondary outcomes (7)
HbA1c change
Evaluation of HbA1c change in each group
Measured: 52 weeks
Body Mass Index change
Evaluation of Body Mass Index change in each group
Measured: 52 weeks
Fatty Liver Index (FLI)
Evaluation of FLI change in each group.
Measured: 52 weeks
Fibrosis-4 Index (FIB-4)
Evaluation of FIB-4 change in each group.
Measured: 52 weeks
Aspartate Aminotransferase to Platelet ratio Index (APRI)
Evaluation of APRI change in each group.
Measured: 52 weeks
NAFLD Fibrosis Score (NFS)
Evaluation of NFS change in each group.
Measured: 52 weeks
Shearwave Elastography (SWE)
Evaluation of SWE change in each group.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Jun 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital, Athens, Greece, Hippocration General Hospital
- Responsible party
- Principal investigator, KOULLIAS EMMANOUIL, National and Kapodistrian University of Athens
- Investigators
- JOHN KOSKINAS, PROFESSOR, Study chair, National and Kapodistrian University of AthensANASTASIA THANOPOULOU, AS PROFESSOR, Study director, National and Kapodistrian University of AthensMELANIE DEUTSCH, AS PROFESSOR, Study chair, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946148
- Sponsor's protocol ID
- SC12/16-6-2016
- Acronym
- NAMELS-18
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after analysis is completed and study results have been published. Expected to happen in 1st Semester of 2024. It will include participants' results of imaging and laboratory examinations in excel files.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dulaglutide vs Empagliflozin on Non-alcoholic Fatty Liver Disease of Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05946148
- Acronym / sponsor ID
- NAMELS-18 / SC12/16-6-2016
- Conditions
- Non-Alcoholic Fatty Liver Disease, Liver Steatosis
- Keywords
- Empagliflozin, Dulaglutide, Liver Steatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Alexandra Hospital, Athens, Greece, Hippocration General Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin group | – | Drug: EmpagliflozinOral Empagliflozin 10mg daily, as add-on to their previous treatment regimen. |
| Dulaglutide group | – | Drug: DulaglutideSubcutaneous Dulaglutide 1.5mg weekly, as add-on to their previous treatment regimen. |
| Control group | – | Drug: Control RxOptimal anti-diabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families), targeting glycemic control. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian, 25-75 years old, diagnosed with type 2 diabetes mellitus and fatty liver.
Key inclusion criteria (1 listed)
- Presence of diabetes mellitus type 2 and non-alcoholic fatty liver Stable anti-diabetic treatment regimen for the past 6 months
Key exclusion criteria (1 listed)
- Recent (last 5 years) medical history of cancer, pancreatitis, viral hepatitis or any other cause of liver disease (alcohol abuse, autoimmune hepatitis, hemochromatosis, heart failure etc.) Recent alteration (<6 months) of anti-diabetic regimen. Already established treatment with GLP1-ras or SGLT2-is prior to screening. Treatment with Pioglitazone. Corticotherapy administration. Pregnant or planning for pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: EEmpagliflozin 10mg daily, as add-on to previous treatment regimen. | Drug | Empagliflozin group |
| DulaglutideAlso: DDulaglutide 1.5mg weekly, as add-on to previous treatment regimen | Drug | Dulaglutide group |
| Control RxAlso: COptimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families. | Drug | Control group |
Primary outcome
Liver Fat Fraction reduction
Time frame: 52 weeks
Change of Liver Fat Fraction as calculated by MRI-PDFF
>30% Liver Fat Fraction reduction
Time frame: 52 weeks
Percentage of each group's participants that achieves >30% Liver Fat Fraction reduction
7 secondary outcomes
HbA1c change
Time frame: 52 weeks
Body Mass Index change
Time frame: 52 weeks
Fatty Liver Index (FLI)
Time frame: 52 weeks
Fibrosis-4 Index (FIB-4)
Time frame: 52 weeks
Aspartate Aminotransferase to Platelet ratio Index (APRI)
Time frame: 52 weeks
NAFLD Fibrosis Score (NFS)
Time frame: 52 weeks
Shearwave Elastography (SWE)
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Yes. IPD will be shared after analysis is completed and study results have been published. Expected to happen in 1st Semester of 2024. It will include participants' results of imaging and laboratory examinations in excel files.
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOHN KOSKINAS, PROFESSOR study chair
National and Kapodistrian University of Athens
ANASTASIA THANOPOULOU, AS PROFESSOR study director
National and Kapodistrian University of Athens
MELANIE DEUTSCH, AS PROFESSOR study chair
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Liver Steatosis, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Fat Fraction reduction (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.