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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01310556
Other study ID # 12.05.2009-131-1068
Secondary ID
Status Completed
Phase N/A
First received March 7, 2011
Last updated June 17, 2011
Start date June 2009
Est. completion date June 2010

Study information

Verified date June 2009
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD).


Description:

Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary artery disease and the relationship between different GMDs and CAD.

Settings: 230 patients with coronary artery disease and without any known GMDs were included the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g Oral Glucose Tolerance Test (OGTT).


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with coronary artery disease and who had no glucose metabolism disorders were included to study.

Exclusion Criteria:

- Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Other:
ogtt for patients with coronary artery disease
75 g OGTT

Locations

Country Name City State
Turkey Gulhane School of Medicine Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of unknown glucose metabolism disorders in patients with coronary artery disease Results: While GMDs were detected in 58.26% (n=134 patients) of CAD patients, 41.74% of them (n=96 patients) were found to have normal glucose metabolism. 1 year Yes
Secondary Fasting and 120 minute glucose levels have relation with vessels' stenosis. Fasting glucose level was found to have a significant correlation with the total number of stenotic coronary vessels (p=0.0001) and the stenosis rate of all vessels . OGTT 120-minute glucose levels were found to have a significant correlation with the total number of stenotic coronary vessels and the stenosis rate of vessels with the exception of LAD. 1 year Yes
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