A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Asker and Baerum Cardiovascular Diabetes Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Combined lifestyle intervention and optimisation of pharmacological treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Structured multi intervention<br>Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal | Drug: Combined lifestyle intervention and optimisation of pharmacological treatment<br>* 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care<br>* Other names: Combination of drugs (predefined) to reach treatment targets;|
| Other: Standard of care<br>Standard care with or without structured care according to national guidelines | Drug: Combined lifestyle intervention and optimisation of pharmacological treatment<br>* 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care<br>* Other names: Combination of drugs (predefined) to reach treatment targets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in 10-year absolute CHD risk |  | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Cardiovascular, Coronary artery disease, Glycemic control, Treatment, Diabetes Mellitus