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| Name | Class |
|---|---|
| Rikshospitalet University Hospital | OTHER |
| University Hospital, Aker | OTHER |
| Sahlgrenska University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured multi intervention | Other | Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal |
|
| Standard of care | Other | Standard care with or without structured care according to national guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined lifestyle intervention and optimisation of pharmacological treatment | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in 10-year absolute CHD risk | 2-year |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odd E Johansen, MD | Asker and Baerum Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asker and Baerum Hospital, Medical Department | Rud | 1309 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25173538 | Background | Ofstad AP, Johansen OE, Gullestad L, Birkeland KI, Orvik E, Fagerland MW, Urheim S, Aakhus S. Neutral impact on systolic and diastolic cardiac function of 2 years of intensified multi-intervention in type 2 diabetes: the randomized controlled Asker and Baerum Cardiovascular Diabetes (ABCD) study. Am Heart J. 2014 Sep;168(3):280-288.e2. doi: 10.1016/j.ahj.2014.03.026. Epub 2014 Jun 9. | |
| 26573616 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation
|
| 2 years and 5 years |
| Effects on health related quality of life | 2 years and 5 years |
| Background |
| Ulimoen GR, Ofstad AP, Endresen K, Gullestad L, Johansen OE, Borthne A. Low-dose CT coronary angiography for assessment of coronary artery disease in patients with type 2 diabetes--a cross-sectional study. BMC Cardiovasc Disord. 2015 Nov 14;15:147. doi: 10.1186/s12872-015-0143-9. |
| 17532067 | Background | Johansen OE, Bjuro T, Endresen K, Blaasaas KG, Birkeland K, Aakhus S, Gullestad L. Heart rate adjustments and analysis of recovery patterns of ST-segment depression in type 2 diabetes. Int J Cardiol. 2008 Jun 23;127(1):129-32. doi: 10.1016/j.ijcard.2007.04.022. Epub 2007 May 25. |
| 17454845 | Background | Johansen OE, Birkeland KI, Orvik E, Flesland O, Wergeland R, Ueland T, Smith C, Endresen K, Aukrust P, Gullestad L. Inflammation and coronary angiography in asymptomatic type 2 diabetic subjects. Scand J Clin Lab Invest. 2007;67(3):306-16. doi: 10.1080/00365510601045088. |
| 23987834 | Background | Ofstad AP, Gullestad L, Orvik E, Aakhus S, Endresen K, Ueland T, Aukrust P, Fagerland MW, Birkeland KI, Johansen OE. Interleukin-6 and activin A are independently associated with cardiovascular events and mortality in type 2 diabetes: the prospective Asker and Baerum Cardiovascular Diabetes (ABCD) cohort study. Cardiovasc Diabetol. 2013 Aug 30;12:126. doi: 10.1186/1475-2840-12-126. |
| 17509068 | Result | Johansen OE, Gullestad L, Blaasaas KG, Orvik E, Birkeland KI. Effects of structured hospital-based care compared with standard care for Type 2 diabetes-The Asker and Baerum Cardiovascular Diabetes Study, a randomized trial. Diabet Med. 2007 Sep;24(9):1019-27. doi: 10.1111/j.1464-5491.2007.02198.x. Epub 2007 May 17. |
| 30851727 | Derived | Arora S, Ofstad AP, Ulimoen GR, Birkeland KI, Endresen K, Gullestad L, Johansen OE. Asymptomatic coronary artery disease in a Norwegian cohort with type 2 diabetes: a prospective angiographic study with intravascular ultrasound evaluation. Cardiovasc Diabetol. 2019 Mar 9;18(1):26. doi: 10.1186/s12933-019-0832-2. |
| 28627980 | Derived | Ofstad AP, Ulimoen GR, Orvik E, Birkeland KI, Gullestad LL, Fagerland MW, Johansen OE. Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death. J Int Med Res. 2017 Oct;45(5):1535-1552. doi: 10.1177/0300060517707674. Epub 2017 Jun 19. |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |