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

Asker and Baerum Cardiovascular Diabetes Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00133718
Enrollment
120
Registered
2005-08-24
Start date
2002-01-31
Completion date
2012-05-29
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, Cardiovascular, Coronary artery disease, Glycemic control, Treatment, Diabetes Mellitus

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.

Interventions

DRUGCombined lifestyle intervention and optimisation of pharmacological treatment

1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin) 2. standard care

Sponsors

Rikshospitalet University Hospital
CollaboratorOTHER
University Hospital, Aker
CollaboratorOTHER
Sahlgrenska University Hospital
CollaboratorOTHER
Asker & Baerum Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction in 10-year absolute CHD risk2-year

Secondary

MeasureTime frame
Effects on cardiovascular events5-year
Effects on hospitalisations5-year
Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)2 years and 5 years
Effects on health related quality of life2 years and 5 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026