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 multiinterventional program (n=120) on cardiovascular risk, anthropometric measures and glucometabolic control; and - to investigate inflammatory markers in this setting.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2006

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 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.

Intervention(s) in this Clinical Trial

• Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment
  • 6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care
• Drug: the "Polypill"

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Structured multi intervention
• Other: 2
  • standard care with or without structured care

Primary Measures

• Reduction in 10-year absolute CHD risk
  • Time Frame: 2-year
    Safety Issue?: Yes

Secondary Measures

• Effects on cardiovascular events
  • Time Frame: 5-year
    Safety Issue?: Yes
• Effects on hospitalisations
  • Time Frame: 5-year
    Safety Issue?: Yes
• Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)
  • Time Frame: 2 years and 5 years
    Safety Issue?: No
• Effects on health related quality of life
  • Time Frame: 2 years and 5 years
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Asker & Baerum Hospital

Overall Clinical Trial Officials and Contacts

Odd E Johansen, MD Principal Investigator Asker and Baerum Hospital  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00133718

Study ID Number: ABCD-study

ClinicalTrials.gov Identifier: NCT00133718

Health Authority: Norway: Norwegian Medicines Agency