Clinical trial NCT06301191: The Effect of Semaglutide on Cardiovascular Markers and Liver Function
Official title: The Effect of Semaglutide on Endothelial Function, Arterial Stiffness and Liver Indices in Patients Witn Type 2 Diabetes Mellitus and NAFLD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Type 2
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 subjects with T2DM and NAFLD, who attended the Diabetes Outpatients Clinic were enrolled in the study. 25 patients will reciece semaglutide 1 mg (treatment group) and 25 patients will receive DPP-4 inhibitors (either linagliptin or alogliptin or vildagliptin or sitagliptin - control group). Exclusion criteria were 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, and previous therapy with a Glucagon-like peptide-1 agonist. None of the female patients was on hormone replacement treatment.

Brief summary: 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.

Detailed description: The cardiovascular benefits of semaglutide are established; however, its effect on surrogate vascular markers and liver function is not known.The aim of our study is to investigate the effects of semaglutide on vascular,endothelial and liver function in patients with type 2 diabetes and non-alcoholic fatty liver disease.

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.

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.

Primary outcomes:
measure: Comparison of arterial stiffness markers difference among treatment groups
timeFrame: 12 months
measure: Comparison of endothelial glycocalyx thickness difference among treatment groups
timeFrame: 12 months
measure: Comparison of liver stiffness difference among treatment groups
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon University General Hospital
Study officials:
References: