A Phase 4 interventional study of Combined lifestyle intervention and optimisation of pharmacological treatment in Type 2 Diabetes Mellitus, sponsored by Asker & Baerum Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Asker & Baerum Hospital · Phase 4, Interventional, and Prevention
The purposes of this study are:
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Asker & Baerum Hospital is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Standard care with or without structured care according to national guidelines
Drug: Combined lifestyle intervention and optimisation of pharmacological treatment
1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin) 2. standard care
Also known as: Combination of drugs (predefined) to reach treatment targets
Reduction in 10-year absolute CHD risk
Time frame: 2-year
Effects on cardiovascular events
Time frame: 5-year
Effects on hospitalisations
Time frame: 5-year
Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)
Time frame: 2 years and 5 years
Effects on health related quality of life
Time frame: 2 years and 5 years
Plan to share: No
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Asker & Baerum Hospital