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
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Odense University Hospital

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

ClinicalTrials.gov 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:
Myocardial Ischemia
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014