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Completed

NCT Number: NCT00133718

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined lifestyle intervention and optimisation of pharmacological treatment

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

Other names: Combination of drugs (predefined) to reach treatment targets

Primary outcomes

  1. Reduction in 10-year absolute CHD risk

    Time frame: 2-year

Secondary outcomes

  1. Effects on cardiovascular events

    Time frame: 5-year

  2. Effects on hospitalisations

    Time frame: 5-year

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

    Time frame: 2 years and 5 years

  4. Effects on health related quality of life

    Time frame: 2 years and 5 years

Sponsors and collaborators

Lead sponsor

Asker & Baerum Hospital

Other

Collaborators

  • Rikshospitalet University Hospital
  • Sahlgrenska University Hospital
  • University Hospital, Aker

Registry information

Official study title

Asker and Baerum Cardiovascular Diabetes Study

Important dates

Study start
2002
Primary completion
2006
Study completion
2012
First posted
Aug 24, 2005
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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