DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy
Effect of DPP4 Inhibitors on Coronary Atherosclerosis in Patients With Diabetes Mellitus on Insulin Therapy
1 other identifier
observational
4,007
1 country
1
Brief Summary
The study aim is to evaluate whether DPP4-inhibitor could reduce coronary atherosclerosis assessed by CT scan in patients receiving insulin for diabetes mellitus. In this retrospective study, changes in obstructive coronary artery disease prevalence and coronary calcium burden between two coronary CT scans will be compared in patients with and without receiving DPP4-inhibitor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2021
CompletedFirst Submitted
Initial submission to the registry
March 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedFebruary 8, 2023
February 1, 2023
11.2 years
March 29, 2021
February 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of obstructive coronary disease
Change in the prevalence of obstructive coronary disease, defined as \>50 percent stenosis in coronary CT scan
one year
Secondary Outcomes (1)
Change in coronary calcium score
one year
Study Arms (2)
DPP4-inhibitor
Patients who were prescribed DPP4-inhibitor during the period between two coronary CT scan.
No DPP4-inhibitor
Patients who were not prescribed DPP4-inhibitor during the period between two coronary CT scan.
Interventions
Prescription of DPP4-inhibitor during the period between the two coronary CT scan
No prescription of DPP4-inhibitor during the period between the two coronary CT scan
Eligibility Criteria
Patients who were diagnosed with diabetes mellitus and receiving chronic insulin therapy will be enrolled. Among those, only patients who underwent more than two times of coronary CT scan will be included.
You may qualify if:
- Diabetes mellitus
- Receiving chronic insulin therapy (prescription of insulin pen)
- Who underwent more than 2 times of coronary CT scan
You may not qualify if:
- Age \<18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bucheon St. Mary's Hospital
Bucheon-si, KS013, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Hyun Ihm, MD,PhD
Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 1, 2021
Study Start
January 1, 2010
Primary Completion
February 24, 2021
Study Completion
March 30, 2021
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share individual participant data, because the clinical medical records using in this study are not open to public.