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

Sponsor:	Asker & Baerum Hospital
Collaborators:	Rikshospitalet University Hospital University Hospital, Aker Sahlgrenska University Hospital, Sweden
Information provided by:	Asker & Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00133718

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment Drug: the "Polypill"

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Asker and Baerum Cardiovascular Diabetes Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	120
Study Start Date:	January 2002
Estimated Study Completion Date:	June 2008
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Structured multi intervention	Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment 6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care Drug: the "Polypill"
2 standard care with or without structured care	Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment 6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133718

Locations

Norway
Asker and Baerum Hospital, Medical Department
RUD, Norway, 1309

Sponsors and Collaborators

Asker & Baerum Hospital

Rikshospitalet University Hospital

University Hospital, Aker

Sahlgrenska University Hospital, Sweden

Investigators

Principal Investigator:

Odd E Johansen, MD

Asker and Baerum Hospital

More Information

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.

Responsible Party:	Asker and Baerum Hospital ( Odd Erik Johansen )
Study ID Numbers:	ABCD-study
Study First Received:	August 23, 2005
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00133718 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:

Diabetes mellitus
Type 2 diabetes mellitus
Cardiovascular
Coronary artery disease

Glycemic control
Treatment
Diabetes Mellitus

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010