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

This study has been completed.
Sponsor:
Collaborators:
Rikshospitalet University Hospital
University Hospital, Aker
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Odd Erik Johansen, Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00133718
First received: August 23, 2005
Last updated: January 23, 2017
Last verified: January 2017
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Combined lifestyle intervention and optimisation of pharmacological treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Masking Description:
Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation
Primary Purpose: Prevention
Official Title: Asker and Baerum Cardiovascular Diabetes Study

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • Reduction in 10-year absolute CHD risk [ Time Frame: 2-year ]

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

Enrollment: 120
Study Start Date: January 2002
Study Completion Date: May 29, 2012
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Combination of drugs (predefined) to reach treatment targets
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 Name: Combination of drugs (predefined) to reach treatment targets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133718

Locations
Norway
Asker and Baerum Hospital, Medical Department
RUD, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Rikshospitalet University Hospital
University Hospital, Aker
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Odd E Johansen, MD Asker and Baerum Hospital
  More Information

Publications:

Responsible Party: Odd Erik Johansen, Study director, Asker & Baerum Hospital
ClinicalTrials.gov Identifier: NCT00133718     History of Changes
Other Study ID Numbers: ABCD-study
Study First Received: August 23, 2005
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Keywords provided by Asker & Baerum Hospital:
Type 2 diabetes mellitus
Cardiovascular
Coronary artery disease
Glycemic control
Treatment
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on March 28, 2017