Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments combined lifestyle interventional program and optimisation of pharmacological treatment, the "polypill"
Sponsor Asker & Baerum Hospital
Collaborator Rikshospitalet University Hospital
Start date January 2002
End date April 2006
Trial size 120 participants
Trial identifier NCT00133718, ABCD-study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Structured multi intervention
combined lifestyle interventional program and optimisation of pharmacological treatment Metformin, Novo Norm, Amaryl, Insulatard, Actos, Levemir, Novorapid, Novo Mix 30, Humalog Mix 25, Humalog, Lantus
6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care
the "polypill"
(Other)
standard care with or without structured care
combined lifestyle interventional program and optimisation of pharmacological treatment Metformin, Novo Norm, Amaryl, Insulatard, Actos, Levemir, Novorapid, Novo Mix 30, Humalog Mix 25, Humalog, Lantus
6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin) standard care

Primary Outcomes

Measure
Reduction in 10-year absolute CHD risk
time frame: 2-year

Secondary Outcomes

Measure
Effects on cardiovascular events
time frame: 5-year
Effects on hospitalisations
time frame: 5-year
Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)
time frame: 2 years and 5 years
Effects on health related quality of life
time frame: 2 years and 5 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Asker and Baerum Cardiovascular Diabetes Study
Principal investigator Odd E Johansen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Asker & Baerum Hospital.