Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00298844
First received: March 1, 2006
Last updated: March 22, 2007
Last verified: March 2007

March 1, 2006
March 22, 2007
January 2006
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Complete list of historical versions of study NCT00298844 on ClinicalTrials.gov Archive Site
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Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient

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

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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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Type 2 Diabetes Mellitus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
January 2010
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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.
Both
20 Years and older
No
Contact: Mikael K. Poulsen, PhD student +45 65414365 doc_mkp@hotmail.com
Contact: Jan E. Henriksen, MD, PhD +45 65414364 jan.erik.henriksen@ouh.fyns-amt.dk
Denmark
 
NCT00298844
021
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Odense University Hospital
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Principal Investigator: Mikael K. Poulsen, PhD student Odense University Hospital
Odense University Hospital
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP