Serum Endostatin Type 2 Diabetic Patients

NCT03404037 | Completed DMC

• 1 other identifier: 3527/20-2-2017
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I

Fifty-five coronary artery disease patients without type 2 DM

Diagnostic Test: serum endostatin level

Group II

Fifty-five coronary artery disease patients with type 2 DM

Diagnostic Test: serum endostatin level

Interventions

serum endostatin level 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

Also known as: Computed tomography

Group I; Group II

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, 44519, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Hazem M Elashmawy, MD. Msc

  Faculty of medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 19, 2018
• Study Start: March 2, 2017
• Primary Completion: November 11, 2017
• Study Completion: December 20, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)