Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A