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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Odense University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01106573
First received: April 19, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  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?

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Odense University hospital
ClinicalTrials.gov Identifier: NCT01106573     History of Changes
Other Study ID Numbers: KBF2010-01
Study First Received: April 19, 2010
Last Updated: April 19, 2010
Health Authority: Denmark: National Board of Health
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Carotid Stenosis
Aneurysm
Aortic Aneurysm
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Arterial Occlusive Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on August 20, 2014