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

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: May 26, 2008
Last updated: October 27, 2011
Last verified: May 2011
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.

Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Peripheral Endothelial Function and Coronary Status in Asymptomatic Type 2 Diabetic Patients: Relations With Coronary Microcirculation Assessed With Trans-thoracic Echo-doppler

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Post-occlusive hyperaemia endothelium-dependent brachial artery dilation [ Time Frame: immediate ]

Secondary Outcome Measures:
  • noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER [ Time Frame: immediate ]
  • cardiac autonomic neuropathy [ Time Frame: immediate ]
  • cardiac transthoracic echography [ Time Frame: immediate ]
  • biologic markers of endothelial function [ Time Frame: immediate ]

Biospecimen Retention:   Samples Without DNA
whole blood, serum

Enrollment: 173
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • type 2 diabetes
  • overweight free of diabetes
  • control

Inclusion criteria :


  • 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.


  • 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
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Please refer to this study by its identifier: NCT00685984

Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition
Bondy, France, 93140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Emmanuel COSSON, MD phD Hôpital Jean Verdier
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00685984     History of Changes
Other Study ID Numbers: P070403
Study First Received: May 26, 2008
Last Updated: October 27, 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Type 2 diabetes
silent myocardial ischemia
endothelial function

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases processed this record on August 18, 2017