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

January 23, 2017 updated by: Odd Erik Johansen, Asker & Baerum Hospital

Asker and Baerum Cardiovascular Diabetes Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • RUD, Norway, 1309
        • Asker and Baerum Hospital, Medical Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Structured multi intervention
Structured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal
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
Other Names:
  • Combination of drugs (predefined) to reach treatment targets
Other: Standard of care
Standard care with or without structured care according to national guidelines
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
Other Names:
  • Combination of drugs (predefined) to reach treatment targets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in 10-year absolute CHD risk
Time Frame: 2-year
2-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asker & Baerum Hospital

Collaborators

Sahlgrenska University Hospital, Sweden
Rikshospitalet University Hospital
University Hospital, Aker

Investigators

  • Principal Investigator: Odd E Johansen, MD, Asker and Baerum Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

May 29, 2012

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCD-study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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