The purpose of this study is: 1) to investigate the extent of cardiovascular complications in a representative cohort (n=135) of adult patients with type 2 diabetes, 2) to examine if modern non-invasive assessment can replace invasive assessment, 3) to determine the effects of a 6 months life-style interventional program on weight, glycemic control and lipids in 60 patients, 4) to determine the effect of a 2-year prospective, randomised multiinterventional program (n=120) on cardiovascular risk, anthropometric measures and glucometabolic control and 5) to investigate inflammatory markers in this setting.

Condition	Intervention
Diabetes Mellitus Type 2 Diabetes Mellitus	Device: Life-style interventional program  Drug: the "Polypill"

Further Study Details: 

Primary Outcomes: Fraction reaching Total cholesterol < 5 mmol/l; Fraction reaching TC/HDL- ratio: < 4; Fraction reaching LDL: < 3 mmol/l; Fraction reaching Triglycerides < 2 mmol/l; Fraction reaching HDL > 1,2 mmol/l; Fraction reaching blood pressure (when no organ damage): < 140/85 mmHg; Fraction reaching BP (when organ damage): < 130/80 mmHg; Fraction reaching HbA1c: < 7.0 %; Fraction achieving normoalbuminuria
Secondary Outcomes: Effects on cardiovascular events; Effects on hospitalisations; Effects on ischemic burden assessed on stress-ecg; Effects on quality of life; Effects on pharmacological treatment; Effects on inflammatory parameters
Expected Total Enrollment:  120

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, ST-HR 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 CAD, hypertension) irrespective of symptoms or signs of CAD.

The participants are included in a randomized-control trial for 2-year where one arm receives standard treatment and one receives treatment after a multi-interventional program.

End-points includes: glycemic control, lipid control, weight control, blood pressure control, effects on inflammatory parameters.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Type 2 diabetes
• Age 18-75 years
• Men and women
• At least one cardiovascular risk factor (i.e hypertension, dyslipidemia, smoking/formerly smoker, premature familial CAD, microalbuminuria)
• Written informed consent given

Exclusion Criteria:

• Unwillingness
• Age < 18 or > 75 years
• Unstable cardiovascular condition
• Unstable medical condition

Norway
      Asker and Baerum Hospital, Medical department, Rud,  1309,  Norway

Study chairs or principal investigators

Odd E Johansen, MD,  Principal Investigator,  Asker and Baerum Hospital   

Study ID Numbers:  ABCD-study
Last Updated:  August 23, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00133718
Health Authority: Norway: Norwegian Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-13