Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients

Peripheral Endothelial Function and Coronary Status in Asymptomatic Type 2 Diabetic Patients: Relations With Coronary Microcirculation Assessed With Trans-thoracic Echo-doppler

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00685984

Acronym

PEFDIA

Enrollment

173

Registered

2008-05-29

Start date

2008-01-31

Completion date

2010-08-31

Last updated

2011-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

Type 2 diabetes, silent myocardial ischemia, endothelial function

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Post-occlusive hyperaemia endothelium-dependent brachial artery dilation	immediate

Secondary

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

Countries

France

Outcome results