The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic PatientsNCT07190144
Coronary Flow Reserve Changes After Semaglutide Treatment
An observational study of The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic Patients and Obesity &Amp; Overweight, run by Ekrem Bilal Karaayvaz at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the effects of semaglutide to coronary artery flow in diabetic and non-diabetic patients. The main question it aims to answer is: Does semaglutide enhance coronary artery flow in diabetic and non-diabetic patients? Participants already planned taking semaglutide… Read more about this study
- Who is it for?
- Ages 28 to 65 years
- Conditions the study is for
- The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic Patients, Obesity &Amp; Overweight
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2025to 1 Aug 2025
- 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 28 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diabetic and non-diabetic and planned to start semaglutide has referred to cardiology clinic for the study.
Who may be able to join
- Patients who were planned to start semaglutide.
Who cannot join
- Ischemic heart disease
- Previous stent implantation or coronary bypass
- Heart failure
- Cardiomyopathies
- Inflammatory diseases
- Autoimmune rheumatic disease
- Chronic liver and renal insufficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medicana International Istanbul Hospital
Istanbul, 34520
About this study
The goal of this observational study is to learn about the effects of semaglutide to coronary artery flow in diabetic and non-diabetic patients. The main question it aims to answer is:
Does semaglutide enhance coronary artery flow in diabetic and non-diabetic patients?
Participants already planned taking semaglutide by an endocrine specialist as their treatment was assessed with CFR before and 3 months after.
- Conditions
- The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic Patients, Obesity &Amp; Overweight
- Keywords
- Coronary Flow Reserve, Semaglutide, Diabetes Mellitus
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic patients | Non-diabetic patients who have planned to given semaglutide by an endocrinology specialist, mostly to give weight, were performed CFR with echocardiography before and 3 months after the treatment. | |
| Diabetic patients | Diabetic patients, who were planned to start semaglutide by an endocrinology specialist and were otherwise has same demographic data as non-diabetic patients, were performed CFR with echocardiography before and 3 months after the treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who had acute coronary syndrome
Semaglutide is known for its beneficial effects on coronary vasculature. If a patient had myocardial infarction, this patient can no longer participate in study because the CFR ultimately changes.
Measured: From start of the study to 3 months after
Secondary outcomes (1)
Number of patients who can not lose weight
Semaglutide is not only a diabetic drug but is also known for its weight loss properties. If the patient is unable to lose weight, additional information should be obtained as to why the drug is not working for this specific patient and should be removed from the study.
Measured: From start to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start7 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekrem Bilal Karaayvaz
- Sponsor type
- University, hospital or other
- Collaborators
- MEDICANA
- Responsible party
- Sponsor-investigator, Ekrem Bilal Karaayvaz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190144
- Sponsor's protocol ID
- IstanbulU-EBKaraayvaz-2
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.
PubMed 27633186Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.
PubMed 37952131
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Flow Reserve Changes After Semaglutide Treatment
- ClinicalTrials.gov ID
- NCT07190144
- Acronym / sponsor ID
- IstanbulU-EBKaraayvaz-2
- Conditions
- The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic Patients, Obesity &Amp; Overweight
- Keywords
- Coronary Flow Reserve, Semaglutide, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Ekrem Bilal KaraayvazUniversity, hospital or other
- Collaborators
- MEDICANA
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Sep 2025 (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.
The goal of this observational study is to learn about the effects of semaglutide to coronary artery flow in diabetic and non-diabetic patients. The main question it aims to answer is:
Does semaglutide enhance coronary artery flow in diabetic and non-diabetic patients?
Participants already planned taking semaglutide by an endocrine specialist as their treatment was assessed with CFR before and 3 months after.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic patients | – | –Non-diabetic patients who have planned to given semaglutide by an endocrinology specialist, mostly to give weight, were performed CFR with echocardiography before and 3 months after the treatment. |
| Diabetic patients | – | –Diabetic patients, who were planned to start semaglutide by an endocrinology specialist and were otherwise has same demographic data as non-diabetic patients, were performed CFR with echocardiography before and 3 months after the treatment |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diabetic and non-diabetic and planned to start semaglutide has referred to cardiology clinic for the study.
Key inclusion criteria (1 listed)
- Patients who were planned to start semaglutide.
Key exclusion criteria (7 listed)
- Ischemic heart disease
- Previous stent implantation or coronary bypass
- Heart failure
- Cardiomyopathies
- Inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who had acute coronary syndrome
Time frame: From start of the study to 3 months after
Semaglutide is known for its beneficial effects on coronary vasculature. If a patient had myocardial infarction, this patient can no longer participate in study because the CFR ultimately changes.
1 secondary outcome
Number of patients who can not lose weight
Time frame: From start to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Results publication: PubMed 27633186Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.
- Results publication: PubMed 37952131Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornoe CW, Ryan DH; SELECT Trial Investigators. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. Epub 2023 Nov 11.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The Study Focused on the Vascular Effects of Semaglutide in Both Diabetic and Non-diabetic Patients and Obesity &Amp; Overweight, run by Ekrem Bilal Karaayvaz at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 24 Sep 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who had acute coronary syndrome (time frame: From start of the study to 3 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07190144, which also lists 2 linked publications.
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 24 Sep 2025.