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

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ClinicalTrials.gov Identifier: NCT00685984
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : October 28, 2011
Information provided by (Responsible Party):
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.

Condition or disease
Myocardial Ischemia

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 Type : Observational
Actual Enrollment : 173 participants
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
Study Start Date : January 2008
Primary Completion Date : June 2010
Study Completion Date : August 2010


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

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

Biospecimen Retention:   Samples Without DNA
whole blood, serum

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00685984     History of Changes
Other Study ID Numbers: P070403
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: May 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