Clinical trial NCT00685984: Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Keywords: Type 2 diabetes
silent myocardial ischemia
endothelial function
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Alfediam
First posted: 2008-05-29
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * type 2 diabetes
* overweight free of diabetes
* control

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.

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 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

Primary outcomes:
measure: Post-occlusive hyperaemia endothelium-dependent brachial artery dilation
timeFrame: immediate
Secondary outcomes:
measure: noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER
timeFrame: immediate
measure: cardiac autonomic neuropathy
timeFrame: immediate
measure: cardiac transthoracic echography
timeFrame: immediate
measure: biologic markers of endothelial function
timeFrame: immediate
Other outcomes:
Locations:
city: Bondy
country: France
facility: Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition
Study officials:
affiliation: Hôpital Jean Verdier
name: Emmanuel COSSON, MD phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cosson E, Pham I, Valensi P, Paries J, Attali JR, Nitenberg A. Impaired coronary endothelium-dependent vasodilation is associated with microalbuminuria in patients with type 2 diabetes and angiographically normal coronary arteries. Diabetes Care. 2006 Jan;29(1):107-12. doi: 10.2337/diacare.29.1.107.
citation: Pham I, Nguyen MT, Valensi P, Rousseau H, Nitenberg A, Vicaut E, Cosson E. Noninvasive study of coronary microcirculation response to a cold pressor test. Eur J Clin Invest. 2015 Feb;45(2):135-43. doi: 10.1111/eci.12389. Epub 2015 Jan 7.
citation: Nguyen MT, Pham I, Valensi P, Rousseau H, Vicaut E, Laguillier-Morizot C, Nitenberg A, Cosson E. Flow-mediated-paradoxical vasoconstriction is independently associated with asymptomatic myocardial ischemia and coronary artery disease in type 2 diabetic patients. Cardiovasc Diabetol. 2014 Jan 15;13:20. doi: 10.1186/1475-2840-13-20.