Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

This study is currently recruiting participants.

Verified by Odense University Hospital, March 2007

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00298844

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 IV

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient

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

Study ID Numbers:	021
Study First Received:	March 1, 2006
Last Updated:	March 22, 2007
ClinicalTrials.gov Identifier:	NCT00298844
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)

Study placed in the following topic categories:

Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Ischemia
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009