The Effect of Semaglutide on Cardiovascular Markers and Liver Function

Sponsor
Attikon Hospital
Study ID
NCT06301191
Status
Unknown

Conditions

  • Diabetes Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide, 1.0 mg/mL — DRUG
    Semaglutide, 1.0 mg/mL
  • Dipeptidyl Peptidase 4 inhibitor — DRUG
    Dipeptidyl Peptidase 4 inhibitor

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Mar 2024
Primary completion
Mar 1, 2023
Completion
May 1, 2024

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Semaglutide group
    25 patients treated with semaglutide. Pulse wave velocity, aumentation index, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using a high-resolution camera with Sideview Darkfield Imaging technique (Microscan, Glucockeck) will be evaluated. PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx.Liver steatosis and stiffness will be measured using Fibroscan® Mini+ 430 (Echosens, Paris, Île-de-France). CAP score will be used as an index of liver fat content, with normal values being \< 238 dB/m. E score will be used as an index of liver fibrosis, with normal values being 2- 6 kPa. Blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 4 and 12 months of treatment.
  • Arm: D-PP4 group
    25 patients treated with D-PP4 inhibitors. Pulse wave velocity, augmentation index, SBPao and PPao with Arteriograph, Mobilograph and Complior, and perfused boundary region (PBR) of sublingual vessels using a high-resolution camera with Sideview Darkfield Imaging technique (Microscan, Glucockeck) will be evaluated. PBR consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx.Liver steatosis and stiffness will be measured using Fibroscan® Mini+ 430 (Echosens, Paris, Île-de-France). CAP score will be used as an index of liver fat content, with normal values being \< 238 dB/m. E score will be used as an index of liver fibrosis, with normal values being 2- 6 kPa. Blood glucose, glycosylated hemoglobin (HbA1c) and a full lipidemic profile will be measured before and at 4 and 12 months of treatment

Primary Outcome Measure

Comparison of arterial stiffness markers difference among treatment groups [ Time Frame: 12 months ]

Central Contacts

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