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NCT00298844 Clinical Trial

Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00298844
Other study ID # 021
Secondary ID
Status Recruiting
Phase Phase 4
First received March 1, 2006
Last updated March 22, 2007
Start date January 2006
Est. completion date January 2010

Study information
Verified date March 2007
Source Odense University Hospital
Contact Mikael K. Poulsen, PhD student
Phone +45 65414365
Email doc_mkp@hotmail.com
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date January 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

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