Diabetes Type 2NCT06301191
The Effect of Semaglutide on Cardiovascular Markers and Liver Function
An observational study of Diabetes Type 2, run by Attikon Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Semaglutide, 1.0 mg/mL and Dipeptidyl Peptidase 4 inhibitor
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2022to 1 May 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diabetes Mellitus type 2
- NAFLD
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Attikon University General Hospital
Athens, 12462
Vaia Lambadiari, Professor, 2105831148, vlambad@otenet.gr
About this study
Official title: The Effect of Semaglutide on Endothelial Function, Arterial Stiffness and Liver Indices in Patients Witn Type 2 Diabetes Mellitus and NAFLD
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.
Read the 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.
- Conditions
- Diabetes Type 2
- Being tested
- Semaglutide, 1.0 mg/mL, Dipeptidyl Peptidase 4 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide, 1.0 mg/mLDrug
Semaglutide, 1.0 mg/mL
Dipeptidyl Peptidase 4 inhibitorDrug
Dipeptidyl Peptidase 4 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 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 Receives: Drug: Dipeptidyl Peptidase 4 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of arterial stiffness markers difference among treatment groups
Comparison of pulse wave velocity difference among treatment groups. Two non-invasive pressure sensors will be used to record the carotid and femoral waveforms and the distance between the two arterial sites will be measured with a tape measure. Pulse wave velocity is calculated as the distance divided by transit time between waves (m/s).
Measured: 12 months
Comparison of endothelial glycocalyx thickness difference among treatment groups
The investigators will measure the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield imaging that provides a direct, noninvasive, and fast method for the assessment of the endothelial glycocalyx. The PBR is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma on the surface of the microvessel lumen. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Thus, an increased perfused boundary region is consistent with deeper penetration of erythrocytes into glycocalyx, indicating a loss of glycocalyx barrier properties and is a marker of reduced glycocalyx thickness.
Measured: 12 months
Comparison of liver stiffness difference among treatment groups
CAP score will be used as an index of liver fat content, with normal values being < 238 dB/m. <237 dB/m (S0, no steatosis), 237 -259 dB/m (S1, mild steatosis), 259 -291 dB/m (S2, moderate steatosis), and 291 -400 dB/m (S3,severe steatosis). E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) <5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) >16.0 kPa (F4, cirrhosis).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301191
- Sponsor's protocol ID
- 133/21-02-2022
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semaglutide on Endothelial Function, Arterial Stiffness and Liver Indices in Patients Witn Type 2 Diabetes Mellitus and NAFLD
- ClinicalTrials.gov ID
- NCT06301191
- Acronym / sponsor ID
- 133/21-02-2022
- Conditions
- Diabetes Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide group | – | Drug: Semaglutide, 1.0 mg/mL25 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. |
| D-PP4 group | – | Drug: Dipeptidyl Peptidase 4 inhibitor25 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diabetes Mellitus type 2
- NAFLD
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide, 1.0 mg/mLSemaglutide, 1.0 mg/mL | Drug | Semaglutide group |
| Dipeptidyl Peptidase 4 inhibitorDipeptidyl Peptidase 4 inhibitor | Drug | D-PP4 group |
Primary outcome
Comparison of arterial stiffness markers difference among treatment groups
Time frame: 12 months
Comparison of pulse wave velocity difference among treatment groups. Two non-invasive pressure sensors will be used to record the carotid and femoral waveforms and the distance between the two arterial sites will be measured with a tape measure. Pulse wave velocity is calculated as the distance divided by transit time between waves (m/s).
Comparison of endothelial glycocalyx thickness difference among treatment groups
Time frame: 12 months
The investigators will measure the perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5 to 25 μm) using Sidestream Darkfield imaging that provides a direct, noninvasive, and fast method for the assessment of the endothelial glycocalyx. The PBR is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma on the surface of the microvessel lumen. The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Thus, an increased perfused boundary region is consistent with deeper penetration of erythrocytes into glycocalyx, indicating a loss of glycocalyx barrier properties and is a marker of reduced glycocalyx thickness.
Comparison of liver stiffness difference among treatment groups
Time frame: 12 months
CAP score will be used as an index of liver fat content, with normal values being < 238 dB/m. <237 dB/m (S0, no steatosis), 237 -259 dB/m (S1, mild steatosis), 259 -291 dB/m (S2, moderate steatosis), and 291 -400 dB/m (S3,severe steatosis). E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) <5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) >16.0 kPa (F4, cirrhosis).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type 2, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VAIA LAMBADIARI, Professor (2105831148, vlambad@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of arterial stiffness markers difference among treatment groups (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.