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Trial record 1 of 1 for:    NCT00298844
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Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

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. Identifier: NCT00298844
Recruitment Status : Unknown
Verified March 2007 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : March 3, 2006
Last Update Posted : March 23, 2007
Information provided by:
Odense University Hospital

Brief Summary:
The study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters

Condition or disease
Type 2 Diabetes Mellitus

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Study Type : Observational
Enrollment : 350 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient
Study Start Date : January 2006
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age: ≥ 20 years.
  • Fasting C-peptide > 300 pmol/l.

Exclusion Criteria:

  • Verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure < 30 mmHg).
  • Suspected short lifespan because of malignant disease or end-stage kidney disease.
  • Pregnancy or planned pregnancy during the study period.
  • Body weight > 150 kg.
  • Physical or mental disability not enabling participation in the study.

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 identifier (NCT number): NCT00298844

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Contact: Mikael K. Poulsen, PhD student +45 65414365
Contact: Jan E. Henriksen, MD, PhD +45 65414364

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Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mikael K. Poulsen, PhD student    +45 6541 4365   
Contact: Jan Erik Henriksen, MD, PhD    +45 6541 4364   
Principal Investigator: Mikael K Poulsen, PhD student         
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Mikael K. Poulsen, PhD student Odense University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00298844     History of Changes
Other Study ID Numbers: 021
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: March 23, 2007
Last Verified: March 2007
Keywords provided by Odense University Hospital:
Type 2 diabetes mellitus
Macrovascular disease
Diastolic dysfunction
Intima media thickness
Single- photon emission computed tomography (SPECT)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases