Type 2 Diabetes Mellitus Clinical Trial
Official title:
Asker and Baerum Cardiovascular Diabetes Study
The purposes of this study are:
- to investigate the extent of cardiovascular complications in a representative cohort
(n=135) of adult patients with type 2 diabetes;
- to examine if modern non-invasive assessment can replace invasive assessment;
- to determine the effects of a 6 month lifestyle interventional program on weight,
glycemic control and lipids in 60 patients;
- to determine the effect of a 2-year prospective, randomised multi-interventional
program (n=120) on cardiovascular risk, anthropometric measures and glycometabolic
control; and
- to investigate inflammatory markers in this setting.
As cardiovascular disease often is silent in type 2 diabetic patients, ways of detecting
this early is of potential benefit, as is probably an aggressive treatment regimen trying to
achieve goals for factors such as blood pressure, glycemic control, lipids, smoking,
physical activity and weight.
This study compares traditional non-invasive tests such as stress-ecg, modern non-invasive
tests such as holter-analysis, modern ECG analysis, stress-ecco cardiography and tissue
Doppler against the gold standard today for assessing coronary artery disease, coronary
angiography, in patients with type 2 diabetes and at least one cv-risk factor (i.e smoking,
premature familial coronary artery disease (CAD)), hypertension) irrespective of symptoms or
signs of CAD.
The participants are included in a randomized-control trial for 2 years where one arm
receives standard treatment and one receives treatment after a multi-interventional program.
End-points include: glycemic control, lipid control, weight control, blood pressure control,
and effects on inflammatory parameters.
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