DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy

February 5, 2023 updated by: Sang Hyun Ihm, MD PhD, The Catholic University of Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4007

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DPP4-inhibitor
Patients who were prescribed DPP4-inhibitor during the period between two coronary CT scan.
Drug: DPP4-inhibitor
Prescription of DPP4-inhibitor during the period between the two coronary CT scan
No DPP4-inhibitor
Patients who were not prescribed DPP4-inhibitor during the period between two coronary CT scan.
Drug: No DPP4-inhibitor
No prescription of DPP4-inhibitor during the period between the two coronary CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of obstructive coronary disease
Time Frame: one year
Change in the prevalence of obstructive coronary disease, defined as >50 percent stenosis in coronary CT scan
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in coronary calcium score
Time Frame: 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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Sang-Hyun Ihm, MD,PhD, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2010

Primary Completion (ACTUAL)

February 24, 2021

Study Completion (ACTUAL)

March 30, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (ACTUAL)

April 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 5, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC21WIDI0044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data, because the clinical medical records using in this study are not open to public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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