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Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

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ClinicalTrials.gov 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
Sponsor:
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

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

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

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.

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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): NCT00298844


Contacts
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

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mikael K. Poulsen, PhD student    +45 6541 4365    doc_mkp@hotmail.com   
Contact: Jan Erik Henriksen, MD, PhD    +45 6541 4364    jan.erik.henriksen@ouh.fyns-amt.dk   
Principal Investigator: Mikael K Poulsen, PhD student         
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Mikael K. Poulsen, PhD student Odense University Hospital

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

ClinicalTrials.gov 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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases