Correlation Between Micro Vascular Complications and Severity of Coronary Artery Disease in Type 2 DM

February 15, 2022 updated by: Islam Khaled Fathy, Sohag University

Diabetes is a major cause of morbidity and mortality worldwide and it contributes substantially to healthcare costs. Type 2 Diabetes mellitus is the most common type of diabetes accounting for approximately (90%) of all cases.

Type 2 DM carries a two to six times risk of death from cardiovascular etiologies, such that age adjusted prevalence of white Americans for coronary artery disease (CAD) is double in those with type 2 DM than those without .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

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

  • Egypt
      • Sohag, Egypt
        • Osama R Elsherief

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study enrolled 100 patients known type 2 DM with coronary artery disease and coronary angiography done to diagnosis coronary artery disease then assess microvascular complications in those patients by fundus examination-neurologic examination-albumin creatinine ratio-EGFR. IN STUDY investigator exclude any other cause can lead to microvascular complications example hypertension.

aim of study to early predict coronary artery disease in patient with type 2 DM if microvascular complication presenet by non invasive investigation as stress ECG.

Description

Inclusion Criteria:

100 Cases were selected with type II (DM) patients who had been admitted for coronary angiography because of suspected (CAD) to the Catheter lab unit of Sohag University Hospital.

Exclusion Criteria:

  1. Type 1 DM.
  2. Smoker.
  3. Hypertension.
  4. Pregnant women.
  5. Patient known non diabetic retinal disease non diabetic. nephropathy or neuropathy.
  6. History of familial dyslipidemia.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients type 2 DM with coronary artery disease and diabetic retinopathy.
Diagnostic test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography.
albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
patients type 2 DM with coronary artery disease and diabetic neuropathy.
Diagnostic test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography.
albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
patients type 2 DM with coronary artery disease and diabetic nephropathy
Diagnostic test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography.
albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
patient type 2 DM with coronary artery disease and non microvascular complications.
Diagnostic test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography.
albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between microvascular complications and severity of coronary disease in type2 DM.
Time Frame: 4 months

outcome of study to assess correlation between coronary artery disease and microvascular complications in type 2 DM to early predict coronary artery disease in patient type 2 DM with microvascular complications by non invasive methods as stress ECG or CT coronary angio or cardiac MRI and prevent serious complications as myocardial infarction.

assess microvascular complication as follow albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
4 months

Collaborators and Investigators

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

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-07-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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.

Clinical Trials on Patients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same Patients

Clinical Trials on albumin creatinine ratio -EGFR-fundus examination- coronary angiography.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe