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Peripheral Endothelial Function and Coronary Status in Asymptomatic Diabetic Patients

NCT ID: NCT00685984

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Myocardial Ischemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

2

No interventions assigned to this group

3

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alfediam

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel COSSON, MD phD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Jean Verdier

Locations

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Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition

Bondy, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 16373905 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25490913 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24428877 (View on PubMed)

Other Identifiers

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P070403

Identifier Type: -

Identifier Source: org_study_id