Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Information provided by:
Odense University Hospital Identifier:
First received: March 1, 2006
Last updated: March 22, 2007
Last verified: March 2007
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 Phase
Type 2 Diabetes Mellitus
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Estimated Enrollment: 350
Study Start Date: January 2006
Estimated Study Completion Date: January 2010

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  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 identifier: NCT00298844

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

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
Principal Investigator: Mikael K. Poulsen, PhD student Odense University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00298844     History of Changes
Other Study ID Numbers: 021 
Study First Received: March 1, 2006
Last Updated: March 22, 2007
Health Authority: Denmark: National Board of Health

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 processed this record on October 21, 2016