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Completed

NCT Number: NCT00685984

Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients

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.

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition

Bondy, 93140, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Post-occlusive hyperaemia endothelium-dependent brachial artery dilation

    Time frame: immediate

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Alfediam

Registry information

Official study title

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

Acronym: PEFDIA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 29, 2008
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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