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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2012-05-29

Brief Summary

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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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Detailed Description

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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

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation

Study Groups

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Structured multi intervention

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

Group Type OTHER

Combined lifestyle intervention and optimisation of pharmacological treatment

Intervention Type DRUG

1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)
2. standard care

Standard of care

Standard care with or without structured care according to national guidelines

Group Type OTHER

Combined lifestyle intervention and optimisation of pharmacological treatment

Intervention Type DRUG

1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)
2. standard care

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Combination of drugs (predefined) to reach treatment targets

Eligibility Criteria

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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