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

October 27, 2011 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • type 2 diabetes
  • overweight free of diabetes
  • control

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
2
3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-occlusive hyperaemia endothelium-dependent brachial artery dilation
Time Frame: immediate
immediate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Alfediam

Investigators

  • Principal Investigator: Emmanuel COSSON, MD phD, Hôpital Jean Verdier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 26, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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