Serum Endostatin Type 2 Diabetic Patients

Completed

• Conditions: Coronary Arteriosclerosis; Diabetes Mellitus, Type 2; Coronary Artery Disease
• Interventions: Diagnostic Test: serum endostatin level

• Registration Number: NCT03404037
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2017-03-02
• Primary Completion: 2017-11-11
• Study Completion: 2017-12-20
• Status Verified: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-18
• Last Update Submitted: 2018-01-18
• Study First Posted: 2018-01-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	serum endostatin level	Fifty-five coronary artery disease patients without type 2 DM
Group II	serum endostatin level	Fifty-five coronary artery disease patients with type 2 DM

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zagazig University, Faculty of Medicine; 🇪🇬 Zagazig, Egypt