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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Combined lifestyle intervention and optimisation of pharmacological treatment

• Registration Number: NCT00133718
• Lead Sponsor: Asker & Baerum Hospital

Brief 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.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Primary Completion: 2006-04
• Study Completion: 2012-05-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured multi intervention	Combined lifestyle intervention and optimisation of pharmacological treatment	Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal
Standard of care	Combined lifestyle intervention and optimisation of pharmacological treatment	Standard care with or without structured care according to national guidelines

Primary Outcome Measures

Name	Time	Method
Reduction in 10-year absolute CHD risk	2-year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asker and Baerum Hospital, Medical Department; 🇳🇴 RUD, Norway