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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Combined lifestyle interventional program and optimisation of pharmacological treatment (Drug); the "Polypill" (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Asker & Baerum Hospital

Official(s) and/or principal investigator(s):
Odd E Johansen, MD, Principal Investigator, Affiliation: Asker and Baerum Hospital

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.

Official title: Asker and Baerum Cardiovascular Diabetes Study

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Reduction in 10-year absolute CHD risk

Secondary outcome:

Effects on cardiovascular events

Effects on hospitalisations

Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)

Effects on health related quality of life

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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

Starting date: January 2002
Ending date: June 2008
Last updated: March 4, 2008