Clinical trial NCT00133718: A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control
Official title: Asker and Baerum Cardiovascular Diabetes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Cardiovascular
Coronary artery disease
Glycemic control
Treatment
Diabetes Mellitus
Lead sponsor: Asker & Baerum Hospital
Sponsor class: OTHER
Collaborators: name: Rikshospitalet University Hospital
name: University Hospital, Aker
name: Sahlgrenska University Hospital
First posted: 2005-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in 10-year absolute CHD risk
timeFrame: 2-year
Secondary outcomes:
measure: Effects on cardiovascular events
timeFrame: 5-year
measure: Effects on hospitalisations
timeFrame: 5-year
measure: Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)
timeFrame: 2 years and 5 years
measure: Effects on health related quality of life
timeFrame: 2 years and 5 years
Other outcomes:
Locations:
city: RUD
country: Norway
facility: Asker and Baerum Hospital, Medical Department
Study officials:
affiliation: Asker and Baerum Hospital
name: Odd E Johansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.