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Completed

NCT Number: NCT04825795

DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving 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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon St. Mary's Hospital

Bucheon-si, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPP4-inhibitor

Drug

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

No DPP4-inhibitor

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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