DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: DPP4-inhibitor; Drug: No DPP4-inhibitor

• Registration Number: NCT04825795
• Lead Sponsor: The Catholic University of Korea

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.

Detailed Description

This is a retrospective study using medical records in two hospitals affiliated to the Catholic University of Korea. Patients with diabetes mellitus who received insulin are retrospectively enrolled. Among those, only patients who underwent coronary CT scan for more than two times will be included. Included patients will be classified into DPP4-inhibitor group and no DPP4-inhibitor group according to the prescribed medication. The changes in obstructive coronary artery disease prevalence and coronary calcium score per one year will be compared between the two groups.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2021-02-24
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study Completion: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4007

Inclusion Criteria

• Diabetes mellitus
• Receiving chronic insulin therapy (prescription of insulin pen)
• Who underwent more than 2 times of coronary CT scan

Exclusion Criteria

• Age <18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DPP4-inhibitor	DPP4-inhibitor	Patients who were prescribed DPP4-inhibitor during the period between two coronary CT scan.
No DPP4-inhibitor	No DPP4-inhibitor	Patients who were not prescribed DPP4-inhibitor during the period between two coronary CT scan.

Primary Outcome Measures

Name	Time	Method
Prevalence of obstructive coronary disease	one year	Change in the prevalence of obstructive coronary disease, defined as \>50 percent stenosis in coronary CT scan

Secondary Outcome Measures

Name	Time	Method
Change in coronary calcium score	one year	Change in coronary calcium score, measured by two coronary CT scan per one year.; Agatston score has minumum value of 0 and no maximum vavlue. Higher agatston score indicated severe calcification and worse outcome

Trial Locations

Locations (1)

Bucheon St. Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of