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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2008 by Asker & Baerum Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Rikshospitalet University Hospital

University Hospital, Aker

Sahlgrenska University Hospital, Sweden

Information provided by:

Asker & Baerum Hospital

ClinicalTrials.gov Identifier:

NCT00133718

First received: August 23, 2005

Last updated: March 4, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2005

Last Updated Date

March 4, 2008

Start Date ^ICMJE

January 2002

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in 10-year absolute CHD risk [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Fraction reaching Total cholesterol < 5 mmol/l
Fraction reaching TC/HDL- ratio: < 4
Fraction reaching LDL: < 3 mmol/l
Fraction reaching triglycerides < 2 mmol/l
Fraction reaching HDL > 1,2 mmol/l
Fraction reaching blood pressure (when no organ damage): < 140/85 mmHg
Fraction reaching BP (when organ damage): < 130/80 mmHg
Fraction reaching HbA1c: < 7.0 %
Fraction achieving normoalbuminuria

Change History

Complete list of historical versions of study NCT00133718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effects on cardiovascular events [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]
Effects on hospitalisations [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]
Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc) [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
Effects on health related quality of life [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Effects on cardiovascular events
Effects on hospitalisations
Effects on ischemic burden assessed on stress-ecg
Effects on quality of life
Effects on pharmacological treatment
Effects on inflammatory parameters

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Asker and Baerum Cardiovascular Diabetes Study

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 multiinterventional program (n=120) on cardiovascular risk, anthropometric measures and glucometabolic 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, ST-HR 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 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment
1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin)
2. standard care
Other Name: Metformin, Novo Norm, Amaryl, Insulatard, Actos, Levemir, Novorapid, Novo Mix 30, Humalog Mix 25, Humalog, Lantus
Drug: the "Polypill"

Study Arm (s)

1
Structured multi intervention
Interventions:
- Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment
- Drug: the "Polypill"
2
standard care with or without structured care

Intervention: Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment

Publications *

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. Epub 2007 May 17.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

120

Estimated Completion Date

June 2008

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00133718

Other Study ID Numbers ^ICMJE

ABCD-study

Has Data Monitoring Committee

Yes

Responsible Party

Odd Erik Johansen, Asker and Baerum Hospital

Study Sponsor ^ICMJE

Asker & Baerum Hospital

Collaborators ^ICMJE

Rikshospitalet University Hospital
University Hospital, Aker
Sahlgrenska University Hospital, Sweden

Investigators ^ICMJE

Principal Investigator:

Odd E Johansen, MD

Asker and Baerum Hospital

Information Provided By

Asker & Baerum Hospital

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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