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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Asker & Baerum Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Rikshospitalet University Hospital
University Hospital, Aker
Sahlgrenska University Hospital, Sweden
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00133718
First received: August 23, 2005
Last updated: March 4, 2008
Last verified: March 2008
History of Changes
  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 multiinterventional program (n=120) on cardiovascular risk, anthropometric measures and glucometabolic control; and
  • to investigate inflammatory markers in this setting.

Condition Intervention
Type 2 Diabetes Mellitus
 Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment
Drug: the "Polypill"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Asker and Baerum Cardiovascular Diabetes Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • Reduction in 10-year absolute CHD risk [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects on cardiovascular events [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]
  • Effects on hospitalisations [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]
  • Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc) [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
  • Effects on health related quality of life [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2002
Estimated Study Completion Date: June 2008
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Structured multi intervention
 Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment
  1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin)
  2. standard care
Other Name: Metformin, Novo Norm, Amaryl, Insulatard, Actos, Levemir, Novorapid, Novo Mix 30, Humalog Mix 25, Humalog, Lantus
Drug: the "Polypill"
2
standard care with or without structured care
 Drug: Combined lifestyle interventional program and optimisation of pharmacological treatment
  1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucosecontrol (metformin, repaglinide/glimepiride, pioglitazone or insulin)
  2. standard care
Other Name: Metformin, Novo Norm, Amaryl, Insulatard, Actos, Levemir, Novorapid, Novo Mix 30, Humalog Mix 25, Humalog, Lantus

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, ST-HR 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 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
Genders Eligible for Study:   Both
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
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, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00133718     History of Changes
Other Study ID Numbers: ABCD-study
Study First Received: August 23, 2005
Last Updated: March 4, 2008
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:
Diabetes mellitus
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
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013