Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients (PEFDIA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Myocardial Ischemia

Study type: Observational

Funder types: Other

Identifiers

NCT00685984

P070403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

FOR TYPE 2 DIABETIC PATIENTS Asymptomatic:

• with normal resting ECG
• coronary primary prevention
• other cardiovascular risk factors justifying screening for silent myocardial ischemia and coronary stenoses in case of silent myocardial ischemia.

FOR PATIENTS WITH OVERWEIGHT:

• Asymptomatic with normal resting ECG
• coronary primary prevention
• Body mass index 25-40 kg/m²
• Without diabetes.

CONTROLS Asymptomatic:

• coronary primary prevention
• Body mass index 18-25 kg/m²
• Without diabetes
• Without cardiovascular risk factors including dyslipidemia, hypertension, smoking habits, No treatment

Exclusion criteria :

• pregnancy
• renal failure
• acrosyndrome

Trial design

173 participants in 3 patient groups

1

2

3