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Serum Endostatin Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03404037
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hazem Mohamed Elashmawy, Zagazig University

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
Diabetes Mellitus, Type 2 Coronary Artery Disease Coronary Arteriosclerosis 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 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 : March 2, 2017
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: 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 Name: Computed tomography




Primary Outcome Measures :
  1. Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease [ Time Frame: 3-Months ]
    Measurement of serum endostatin and Coronary artery calcification in type 2 diabetic patients patients and non-diabetic patients.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
One hundred ten out documented CAD subjects were divided into two groups; group I (Fifty-five CAD patients without T2DM) and group II (Fifty-five CAD patients with T2DM) addmitted to Zagazig University hospital. Egypt
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404037


Locations
Egypt
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

Responsible Party: Hazem Mohamed Elashmawy, Professor of Internal Medicine, Zagazig University
ClinicalTrials.gov Identifier: NCT03404037     History of Changes
Other Study ID Numbers: 3527/20-2-2017
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Arteriosclerosis
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors