Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients

Myocardial Ischemia Clinical Trial

— PEFDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685984
• Other study ID #: P070403
• Status: Completed
• Phase: N/A
• First received: May 26, 2008
• Last updated: October 27, 2011
• Start date: January 2008
• Est. completion date: August 2010

Study information

• Verified date: May 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition	Bondy

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Alfediam

Country where clinical trial is conducted

France, 

References & Publications (1)

Cosson E, Pham I, Valensi P, Pariès J, Attali JR, Nitenberg A. Impaired coronary endothelium-dependent vasodilation is associated with microalbuminuria in patients with type 2 diabetes and angiographically normal coronary arteries. Diabetes Care. 2006 Jan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-occlusive hyperaemia endothelium-dependent brachial artery dilation		immediate	No
Secondary	noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER		immediate	No
Secondary	cardiac autonomic neuropathy		immediate	No
Secondary	cardiac transthoracic echography		immediate	No
Secondary	biologic markers of endothelial function		immediate	No