NCT07190144

Brief 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 by an endocrine specialist as their treatment was assessed with CFR before and 3 months after.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 17, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

Coronary Flow ReserveSemaglutideDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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.

    From start of the study to 3 months after

Secondary Outcomes (1)

  • Number of patients who can not lose weight

    From start to 3 months

Study Arms (2)

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

Eligibility Criteria

Age28 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were diabetic and non-diabetic and planned to start semaglutide has referred to cardiology clinic for the study.

You may qualify if:

  • Patients who were planned to start semaglutide.

You may not qualify if:

  • Ischemic heart disease
  • Previous stent implantation or coronary bypass
  • Heart failure
  • Cardiomyopathies
  • Inflammatory diseases
  • Autoimmune rheumatic disease
  • Chronic liver and renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicana International Istanbul Hospital

Istanbul, 34520, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 27633186BACKGROUND
  • Lincoff 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.

    PMID: 37952131BACKGROUND

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 24, 2025

Study Start

January 7, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations