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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106573
First Posted: April 20, 2010
Last Update Posted: April 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
  Purpose

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.


Condition
Coronary Artery Disease Arteriosclerosis Carotid Stenosis Thrombosis 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)
  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106573


Contacts
Contact: Maria Lyck Hansen, Ph.d student 004540828020 maria.lyck.hansen@ouh.regionsyddanmark.dk
Contact: Lars Melholt Rasmussen, Professor, MD 0045-6541 4506 lars.melholt.rasmussen@ouh.regionsyddanmark.dk

Locations
Denmark
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
Investigators
Study Chair: Lars Melholt Rasmussen, Professor, MD Department of Biochemnistry and Farmacology, Odense University Hospital
  More Information

Responsible Party: Odense University hospital
ClinicalTrials.gov Identifier: NCT01106573     History of Changes
Other Study ID Numbers: KBF2010-01
First Submitted: April 19, 2010
First Posted: April 20, 2010
Last Update Posted: April 20, 2010
Last Verified: April 2010

Keywords provided by Odense University Hospital:
Diabetes Mellitus
Arteriosclerosis
Intima media thickness
arterial stiffness
pulsewave velocity
fibulin-1

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aneurysm
Thrombosis
Aortic Aneurysm
Arteriosclerosis
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