Serum Endostatin Type 2 Diabetic Patients

Coronary Artery Disease Clinical Trial

Official title:

Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients With Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404037
• Other study ID #: 3527/20-2-2017
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 18, 2018
• Start date: March 2, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 20, 2017
• Est. primary completion date: November 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig University, Faculty of Medicine	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease	Measurement of serum endostatin and Coronary artery calcification in type 2 diabetic patients patients and non-diabetic patients.	3-Months