Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

NCT ID: NCT00298844

Last Updated: 2007-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Mikael K. Poulsen, PhD student

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mikael K. Poulsen, PhD student

Role: CONTACT

+45 65414365

Jan E. Henriksen, MD, PhD

Role: CONTACT

+45 65414364

Facility Contacts

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Mikael K. Poulsen, PhD student

Role: primary

+45 6541 4365

Jan Erik Henriksen, MD, PhD

Role: backup

+45 6541 4364

References

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Pedersen L, Nybo M, Poulsen MK, Henriksen JE, Dahl J, Rasmussen LM. Plasma calprotectin and its association with cardiovascular disease manifestations, obesity and the metabolic syndrome in type 2 diabetes mellitus patients. BMC Cardiovasc Disord. 2014 Dec 19;14:196. doi: 10.1186/1471-2261-14-196.

Reference Type DERIVED
PMID: 25527236 (View on PubMed)

Poulsen MK, Dahl JS, Henriksen JE, Hey TM, Hoilund-Carlsen PF, Beck-Nielsen H, Moller JE. Left atrial volume index: relation to long-term clinical outcome in type 2 diabetes. J Am Coll Cardiol. 2013 Dec 24;62(25):2416-2421. doi: 10.1016/j.jacc.2013.08.1622. Epub 2013 Sep 24.

Reference Type DERIVED
PMID: 24076532 (View on PubMed)

Poulsen MK, Nybo M, Dahl J, Hosbond S, Poulsen TS, Johansen A, Hoilund-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. doi: 10.1186/1475-2840-10-76.

Reference Type DERIVED
PMID: 21838881 (View on PubMed)

Poulsen MK, Henriksen JE, Vach W, Dahl J, Moller JE, Johansen A, Gerke O, Haghfelt T, Hoilund-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. doi: 10.1007/s00125-009-1646-7. Epub 2010 Jan 14.

Reference Type DERIVED
PMID: 20225395 (View on PubMed)

Poulsen MK, Henriksen JE, Dahl J, Johansen A, Gerke O, Vach W, Haghfelt T, Hoilund-Carlsen PF, Beck-Nielsen H, Moller 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. doi: 10.1161/CIRCIMAGING.109.855510. Epub 2009 Oct 21.

Reference Type DERIVED
PMID: 19846730 (View on PubMed)

Poulsen MK, Henriksen JE, Dahl J, Johansen A, Moller JE, Gerke O, Vach W, Haghfelt T, Beck-Nielsen H, Hoilund-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. doi: 10.1007/s12350-009-9118-5. Epub 2009 Aug 14.

Reference Type DERIVED
PMID: 19685102 (View on PubMed)

Other Identifiers

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021

Identifier Type: -

Identifier Source: org_study_id

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