Serum Endostatin Type 2 Diabetic Patients

NCT ID: NCT03404037

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-02

Study Completion Date

2017-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Coronary Artery Disease Coronary Arteriosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

Fifty-five coronary artery disease patients without type 2 DM

serum endostatin level

Intervention Type DIAGNOSTIC_TEST

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

Group II

Fifty-five coronary artery disease patients with type 2 DM

serum endostatin level

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Computed tomography

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hazem Mohamed Elashmawy

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hazem M Elashmawy, MD. Msc

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Zagazig University

Locations

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Zagazig University, Faculty of Medicine

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3527/20-2-2017

Identifier Type: -

Identifier Source: org_study_id

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