Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT00685984
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.

Detailed Description

Coronary microcirculation, non invasively assessed with trans-thoracic echo-doppler (coronary blood flow before and after cold pressure testing), and biochemical markers of endothelial dysfunction will also be measured. Correlations between peripheral and coronary endothelial functions will be checked. The measurements will be performed and validated in two other groups

* 30 patients with overweight but free of diabetes, matched with the patients with diabetes for age, gender and body mass index

* 30 control subjects.Reproducibility of the methods will be assessed in 10 patients of the three groups of subjects.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Status Verified: 2011-05
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-occlusive hyperaemia endothelium-dependent brachial artery dilation	immediate

Secondary Outcome Measures

Name	Time	Method
cardiac autonomic neuropathy	immediate
noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER	immediate
cardiac transthoracic echography	immediate
biologic markers of endothelial function	immediate

Trial Locations

Locations (1)

Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition; 🇫🇷 Bondy, France