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NCT01106573 Clinical Trial

Associations Between Diabetes, Arterial Stiffness and Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?

Coronary Artery Disease Clinical Trial

Official title:
Is There an Association Between the Presence of Diabetes, the Degree of Arterial Stiffness and a New Plasma Marker for Vascular Elasticity, Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01106573
Other study ID # KBF2010-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 19, 2010
Last updated April 19, 2010
Start date June 2010
Est. completion date May 2013

Study information
Verified date April 2010
Source Odense University Hospital
Contact Maria Lyck Hansen, Ph.d student
Phone 004540828020
Email maria.lyck.hansen@ouh.regionsyddanmark.dk
Is FDA regulated No
Health authority Denmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and these patients, as a consequence herby, has a lesser prognosis. DM is often related to increased arterial stiffness and hypertension. The investigators thesis is that DM and pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is under-diagnosed. At the same time the investigators imagine that DM is closely related to the degree of arterial stiffness, and that these parameters are closely related to a new biochemical marker, fibulin-1.

The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if there is a connection between the degree of the dysmetabolism and arterial disease, by studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the investigators newly have identified. The results of this project will give us a measure for the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell us more in terms of the connections between a newly identified plasma arterial marker, arterial stiffness and diabetes.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1400
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >18 years of age

- undergoing heart- or vascular surgery

Exclusion Criteria:

- Physical or mental disability not enabling participation in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Biochemnistry and Farmacology, Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

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