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

This study has been completed.
Sponsor:
Collaborator:
Alfediam
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00685984
First received: May 26, 2008
Last updated: October 27, 2011
Last verified: May 2011
History of Changes
  Purpose

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
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • cardiac autonomic neuropathy [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • cardiac transthoracic echography [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • biologic markers of endothelial function [ Time Frame: immediate ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • type 2 diabetes
  • overweight free of diabetes
  • control
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685984

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

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00685984     History of Changes
Other Study ID Numbers: P070403
Study First Received: May 26, 2008
Last Updated: October 27, 2011
Health Authority: France: Ministry of Health

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
Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013