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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Odense University Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Odense University Hospital Identifier:
First received: April 19, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted

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.

Coronary Artery Disease
Carotid Stenosis
Aortic Aneurysm, Abdominal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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?

Further study details as provided by Odense University Hospital:

Biospecimen Retention:   Samples With DNA
In this study we will collect serum, whole blood and urine

Estimated Enrollment: 1400
Study Start Date: June 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The cohort will be selected from patients undergoing planned heart and vascular surgery at our department.

Inclusion Criteria:

  • >18 years of age
  • undergoing heart- or vascular surgery

Exclusion Criteria:

  • Physical or mental disability not enabling participation in the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01106573

Contact: Maria Lyck Hansen, Ph.d student 004540828020
Contact: Lars Melholt Rasmussen, Professor, MD 0045-6541 4506

Department of Biochemnistry and Farmacology, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Principal Investigator: Maria Lyck Hansen, Ph.d student         
Sponsors and Collaborators
Odense University Hospital
Study Chair: Lars Melholt Rasmussen, Professor, MD Department of Biochemnistry and Farmacology, Odense University Hospital
  More Information

Responsible Party: Odense University hospital Identifier: NCT01106573     History of Changes
Other Study ID Numbers: KBF2010-01
Study First Received: April 19, 2010
Last Updated: April 19, 2010

Keywords provided by Odense University Hospital:
Diabetes Mellitus
Intima media thickness
arterial stiffness
pulsewave velocity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Aneurysm
Carotid Stenosis
Aortic Aneurysm, Abdominal
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Aortic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 25, 2017