Asker and Baerum Cardiovascular Diabetes Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Reduction in 10-year absolute CHD risk
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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
Arms & Interventions
Standard of care
Standard care with or without structured care according to national guidelines
Intervention: Combined lifestyle intervention and optimisation of pharmacological treatment (Drug)
Structured multi intervention
Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal
Intervention: Combined lifestyle intervention and optimisation of pharmacological treatment (Drug)
Outcomes
Primary Outcomes
Reduction in 10-year absolute CHD risk
Time Frame: 2-year
Secondary Outcomes
- Effects on cardiovascular events(5-year)
- Effects on hospitalisations(5-year)
- Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)(2 years and 5 years)
- Effects on health related quality of life(2 years and 5 years)
Investigators
Odd Erik Johansen
Study director
Asker & Baerum Hospital