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

April 19, 2010 updated by: Odense University Hospital

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

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Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Department of Biochemnistry and Farmacology, Odense University Hospital

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The cohort will be selected from patients undergoing planned heart and vascular surgery at our department.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Physical or mental disability not enabling participation in the study

Study Plan

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How is the study designed?

Design Details

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Odense University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Lars Melholt Rasmussen, Professor, MD, Department of Biochemnistry and Farmacology, Odense University Hospital

Study record dates

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Study Major Dates

Study Start

Study Start

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June 1, 2010

Primary Completion (Anticipated)

Primary Completion

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May 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

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April 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KBF2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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