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

Asker & Baerum Hospital

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Combined lifestyle intervention and optimisation of pharmacological treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00133718

ABCD-study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Structured multi intervention

Other group

Description:

Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal

Treatment:

Drug: Combined lifestyle intervention and optimisation of pharmacological treatment

Standard of care

Other group

Description:

Standard care with or without structured care according to national guidelines

Treatment:

Drug: Combined lifestyle intervention and optimisation of pharmacological treatment