NCT04825795

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

87
On Track

Trial Health Score

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

Enrollment
4,007

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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 1, 2010

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

11.2 years

First QC Date

March 29, 2021

Last Update Submit

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.

Drug: DPP4-inhibitor

No DPP4-inhibitor

Patients who were not prescribed DPP4-inhibitor during the period between two coronary CT scan.

Drug: No DPP4-inhibitor

Interventions

Prescription of DPP4-inhibitor during the period between the two coronary CT scan

DPP4-inhibitor

No prescription of DPP4-inhibitor during the period between the two coronary CT scan

No DPP4-inhibitor

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Sang-Hyun Ihm, MD,PhD

    Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

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.

Locations