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NCT04825795 Clinical Trial

DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy

Diabetes Mellitus Clinical Trial

Official title:
Effect of DPP4 Inhibitors on Coronary Atherosclerosis in Patients With Diabetes Mellitus on Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04825795
Other study ID # XC21WIDI0044
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date March 30, 2021

Study information
Verified date February 2023
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 4007
Est. completion date March 30, 2021
Est. primary completion date February 24, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DPP4-inhibitor
Prescription of DPP4-inhibitor during the period between the two coronary CT scan
• No DPP4-inhibitor
No prescription of DPP4-inhibitor during the period between the two coronary CT scan

Locations
Country Name City State
Korea, Republic of Bucheon St. Mary's Hospital Bucheon

Sponsors (1)
Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change in coronary calcium score 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		 one year
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