NCT00133718

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Asker & Baerum Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Combined 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

Timeline

• Start date: 2002-01-01
• Primary completion: 2006-04-01
• Completion: 2012-05-29
• First posted: 2005-08-24
• Last updated: 2017-01-24

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated drug study