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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Asker and Baerum Cardiovascular Diabetes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133718
• Other study ID #: ABCD-study
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2005
• Last updated: January 23, 2017
• Start date: January 2002
• Est. completion date: May 29, 2012

Study information

• Verified date: January 2017
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 29, 2012
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Combined lifestyle intervention and optimisation of pharmacological treatment
6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care

Locations

Country	Name	City	State
Norway	Asker and Baerum Hospital, Medical Department	RUD

Sponsors (4)

Lead Sponsor	Collaborator
Asker & Baerum Hospital	Rikshospitalet University Hospital, Sahlgrenska University Hospital, Sweden, University Hospital, Aker

Country where clinical trial is conducted

Norway, 

References & Publications (6)

Johansen OE, Birkeland KI, Orvik E, Flesland Ø, 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. — View Citation

Johansen OE, Bjurö 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. — View 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 — View 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 Bærum Cardiovascular Diabetes (ABCD) cohort study. Cardiovasc Diabetol. 2013 Aug 30;12:126. doi: 10.1186/1475-2840-12-126. — View 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 Bærum Cardiovascular Diabetes (ABCD) study. Am Heart J. 2014 Sep;168(3):280-288.e2. doi: 10.1016/j.ahj.2014.03.026. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in 10-year absolute CHD risk		2-year
Secondary	Effects on cardiovascular events		5-year
Secondary	Effects on hospitalisations		5-year
Secondary	Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)		2 years and 5 years
Secondary	Effects on health related quality of life		2 years and 5 years