The Effect of Semaglutide on Cardiovascular Markers and Liver Function
NCT ID: NCT06301191
Last Updated: 2024-03-08
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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RECRUITING
50 participants
OBSERVATIONAL
2022-03-01
2024-05-01
Brief Summary
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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.
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Detailed Description
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A.Overall, 50 patients with diabetes mellitus type 2 and NAFLD will be studied at baseline ,at four and twelve months of treatment:
25 patients will be treated with semaglutide 25 patients will be treated with D-PP4 inhibitors. B. In all patients, the investigators will measure the pulse wave velocity (measured in m/s), pulse wave augmentation index \[which is calculated by the formula (P2-P1)/PP x 100, where P1 stands for peak systolic pressure, P2 stands for second peak systolic pressure due to wave reflection and PP stands for Pulse Pressure \], central systolic blood pressure (SBPao, measured in mm Hg) and central pulse pressure (PPao, measured ) with Arteriograph, Mobilograph and Complior, and perfused boundary region of sublingual vessels (5-25 μm in size) using a high-resolution camera with Sideview Darkfield Imaging technique (Microscan, Glucockeck). Perfused boundary region consists the cell-free space which is formed from the separation of red blood cells from plasma at the surface of the endothelial glycocalyx. Increased Perfused boundary region is considered to be an accurate indicator of the reduction of endothelial glycocalyx thickness due to plasma penetration into the glycocalyx.Liver steatosis and stiffness will be measured using Fibroscan® Mini+ 430 (Echosens, Paris, Île-de-France). Controlled Attenuation Parameter (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.
The examination will be carried out at the Laboratory of Preventive Cardiology of the 2nd Department of Cardiology of the University of Athens at "Attikon" Hospital.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Semaglutide, 1.0 mg/mL
Semaglutide, 1.0 mg/mL
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
Dipeptidyl Peptidase 4 inhibitor
Dipeptidyl Peptidase 4 inhibitor
Interventions
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Semaglutide, 1.0 mg/mL
Semaglutide, 1.0 mg/mL
Dipeptidyl Peptidase 4 inhibitor
Dipeptidyl Peptidase 4 inhibitor
Eligibility Criteria
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Inclusion Criteria
* NAFLD
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Locations
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Attikon University General Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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133/21-02-2022
Identifier Type: -
Identifier Source: org_study_id
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