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Serum Endostatin Type 2 Diabetic Patients

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT03404037
Collaborator
(none)
110
Enrollment
1
Location
9.6
Actual Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: serum endostatin level

Detailed Description

elevated serum endostatin levels were independently associated with increased risk, severity and progression of coronary artery calcification independent of traditional cardiovascular disease risk factors in T2DM subjects with known coronary artery disease. So, Measurement of serum ES levels can improve the diagnosis of coronary artery calcification and could be useful as a high sensitive marker for the presence and progression of atherosclerosis in T2DM patients.

Study Design

Study Type:
Observational
Actual Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients With Coronary Heart Disease
Actual Study Start Date :
Mar 2, 2017
Actual Primary Completion Date :
Nov 11, 2017
Actual Study Completion Date :
Dec 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Group I

Fifty-five coronary artery disease patients without type 2 DM

Diagnostic Test: serum endostatin level
An oral (metoprolol 20 mg) was given to the patients with heart rates > 60 beats/minute and had no contraindications to beta-blockers, one hour before the scan. Sublingual nitroglycerin was given to all patients before CT examination. A 64-slice CT scanner (Sensation 64; Siemens Medical System, Germany) was used for imaging all subjects. All CT examinations were done during inspiratory breath holding. Endostatin levels were measured using a sandwich ELISA kit according to the manufacturer's instructions endostatin ELISA kit (R&D Systems, Minneapolis, Minnesota, USA
Other Names:
  • Computed tomography

    		•
    Group II

    Fifty-five coronary artery disease patients with type 2 DM

    Diagnostic Test: serum endostatin level
    An oral (metoprolol 20 mg) was given to the patients with heart rates > 60 beats/minute and had no contraindications to beta-blockers, one hour before the scan. Sublingual nitroglycerin was given to all patients before CT examination. A 64-slice CT scanner (Sensation 64; Siemens Medical System, Germany) was used for imaging all subjects. All CT examinations were done during inspiratory breath holding. Endostatin levels were measured using a sandwich ELISA kit according to the manufacturer's instructions endostatin ELISA kit (R&D Systems, Minneapolis, Minnesota, USA
    Other Names:
  • Computed tomography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease [3-Months]

      Measurement of serum endostatin and Coronary artery calcification in type 2 diabetic patients patients and non-diabetic patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: - Patients were between the ages of 50 and 70 years at enrollment.

    • Symptomatic or previously recognized coronary artery disease for all the study population.

    • Type 2 diabetic patients with the onset of type 2 diabetes occurred at age 30 years or older with no history of ketoacidosis for group II subjects.

    Exclusion Criteria:
    • left ventricular ejection fraction (LVEF) ≤40%, chronic heart failure, unstable angina, Myocardial infarction, arrhythmia, valvular heart disease, coronary artery bypass surgery, and history of stent placement, liver diseases, malignancy, glomerular filtration rate index < 35 mL/min/m2, serum creatinine level above 4.5 mg/dL, body mass index >30 kg/m2 or < 15 kg/m2, pulmonary edema, stroke, acute infections, severe trauma, recent surgery, inflammatory conditions, thyrotoxicosis, pregnancy and known allergic reactions.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University, Faculty of Medicine Zagazig Egypt 44519

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Hazem M Elashmawy, MD. Msc, Faculty of medicine, Zagazig University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hazem Mohamed Elashmawy, Professor of Internal Medicine, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT03404037
    Other Study ID Numbers:
    • 3527/20-2-2017
    First Posted:
    Jan 19, 2018
    Last Update Posted:
    Jan 19, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Arteriosclerosis
    Diabetes Mellitus, Type 2
    Endostatins

    Study Results

    No Results Posted as of Jan 19, 2018