Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05946148
Other study ID # SC12/16-6-2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date May 31, 2021

Study information

Verified date July 2023
Source National and Kapodistrian University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria: Presence of diabetes mellitus type 2 and non-alcoholic fatty liver Stable anti-diabetic treatment regimen for the past 6 months Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Greece "Hippocration" General Hospital of Athens Athens Attiki

Sponsors (3)

Lead Sponsor Collaborator
National and Kapodistrian University of Athens Alexandra Hospital, Athens, Greece, Hippocration General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Liver Fat Fraction reduction Change of Liver Fat Fraction as calculated by MRI-PDFF 52 weeks
Primary >30% Liver Fat Fraction reduction Percentage of each group's participants that achieves >30% Liver Fat Fraction reduction 52 weeks
Secondary HbA1c change Evaluation of HbA1c change in each group 52 weeks
Secondary Body Mass Index change Evaluation of Body Mass Index change in each group 52 weeks
Secondary Fatty Liver Index (FLI) Evaluation of FLI change in each group. 52 weeks
Secondary Fibrosis-4 Index (FIB-4) Evaluation of FIB-4 change in each group. 52 weeks
Secondary Aspartate Aminotransferase to Platelet ratio Index (APRI) Evaluation of APRI change in each group. 52 weeks
Secondary NAFLD Fibrosis Score (NFS) Evaluation of NFS change in each group. 52 weeks
Secondary Shearwave Elastography (SWE) Evaluation of SWE change in each group. 52 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04671186 - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Completed NCT05006885 - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) Phase 1
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Recruiting NCT05618626 - Prevention of NAFLD and CVD Through Lifestyle Intervention N/A
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Enrolling by invitation NCT06152991 - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy Phase 3
Completed NCT03681457 - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects Phase 1
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4