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

History of Changes

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 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:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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):

Poulsen MK, Nybo M, Dahl J, Hosbond S, Poulsen TS, Johansen A, Høilund-Carlsen PF, Beck-Nielsen H, Rasmussen LM, Henriksen JE. Plasma osteoprotegerin is related to carotid and peripheral arterial disease, but not to myocardial ischemia in type 2 diabetes mellitus. Cardiovasc Diabetol. 2011 Aug 12;10:76.

Poulsen MK, Henriksen JE, Vach W, Dahl J, Møller JE, Johansen A, Gerke O, Haghfelt T, Høilund-Carlsen PF, Beck-Nielsen H. Identification of asymptomatic type 2 diabetes mellitus patients with a low, intermediate and high risk of ischaemic heart disease: is there an algorithm? Diabetologia. 2010 Apr;53(4):659-67. Epub 2010 Jan 14.

Poulsen MK, Henriksen JE, Dahl J, Johansen A, Gerke O, Vach W, Haghfelt T, Høilund-Carlsen PF, Beck-Nielsen H, Møller JE. Left ventricular diastolic function in type 2 diabetes mellitus: prevalence and association with myocardial and vascular disease. Circ Cardiovasc Imaging. 2010 Jan;3(1):24-31. Epub 2009 Oct 21.

Poulsen MK, Henriksen JE, Dahl J, Johansen A, Møller JE, Gerke O, Vach W, Haghfelt T, Beck-Nielsen H, Høilund-Carlsen PF. Myocardial ischemia, carotid, and peripheral arterial disease and their interrelationship in type 2 diabetes patients. J Nucl Cardiol. 2009 Nov-Dec;16(6):878-87. Epub 2009 Aug 14.

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 May 16, 2013

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