A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control
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.
Timeline
- Start
- 2002-01
- Primary completion
- 2006-04
- Completion
- 2012-05-29
Outcome
Mixed primary results
paper The primary outcome was change in the estimated 10-year absolute risk for fatal coronary heart disease (CHD). PMID 17509068 ↗
paper as well as for the estimated 10-year CHD-risk (17.9% to 14.5% vs. 18.3% to 19.6%) PMID 17509068 ↗
paper The primary outcome was time to any first severe CV event or death. PMID 28627980 ↗
paper with a hazard ratio (HR) if allocated to the multi-intervention group of 1.73 (95% confidence interval (CI) 0.80, 3.75). PMID 28627980 ↗
paper failed to reduce CV outcomes and deaths. PMID 28627980 ↗
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Results 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | — | — |
| Subject | Insulin | Protein / enzyme biologic | — | — |
| Subject | Metformin | Small molecule | — | — |
| Subject | Pioglitazone | Small molecule | — | — |
| Subject | Repaglinide | Small molecule | — | — |