Clinical trial

The Effect of Semaglutide on Endothelial Function, Arterial Stiffness and Liver Indices in Patients Witn Type 2 Diabetes Mellitus and NAFLD

Name
133/21-02-2022
Description
Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study. 25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors. At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function.
Trial arms
Trial start
2022-03-01
Estimated PCD
2023-03-01
Trial end
2024-05-01
Status
Recruiting
Treatment
Semaglutide, 1.0 mg/mL
Semaglutide, 1.0 mg/mL
Arms:
Semaglutide group
Dipeptidyl Peptidase 4 inhibitor
Dipeptidyl Peptidase 4 inhibitor
Arms:
D-PP4 group
Size
50
Primary endpoint
Comparison of arterial stiffness markers difference among treatment groups
12 months
Comparison of endothelial glycocalyx thickness difference among treatment groups
12 months
Comparison of liver stiffness difference among treatment groups
12 months
Eligibility criteria
Inclusion Criteria: * Diabetes Mellitus type 2 * NAFLD Exclusion Criteria: * malignancies * chronic inflammatory disease * chronic kidney disease (estimated glomerular filtration rate \<60 ml/min/m2 for a period of at least 90 days) * peripheral vascular disease * retinopathy * previous therapy with a Glucagon-like peptide-1 agonist. * None of the female patients was on hormone replacement treatment.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample obtained from the subjects for oxidative stress markers (malondialdehyde and protein carbonyls), nitrites and nitrates, N-terminal pro B-type natriuretic peptide (NT-proBNP) measuring.'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-03-08

1 organization

2 products

1 indication

Organization
Attikon Hospital
Indication
Type 2 Diabetes