NCT00133718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2012

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

4.2 years

First QC Date

August 23, 2005

Last Update Submit

January 23, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusCardiovascularCoronary artery diseaseGlycemic controlTreatmentDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Reduction in 10-year absolute CHD risk

    2-year

Secondary Outcomes (4)

  • Effects on cardiovascular events

    5-year

  • Effects on hospitalisations

    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

Study Arms (2)

Structured multi intervention

OTHER

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

Standard of care

OTHER

Standard care with or without structured care according to national guidelines

Drug: Combined lifestyle intervention and optimisation of pharmacological treatment

Interventions

Combined lifestyle intervention and optimisation of pharmacological treatmentDRUG

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

Also known as: Combination of drugs (predefined) to reach treatment targets
Standard of careStructured multi intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwillingness
  • Age \< 18 or \> 75 years
  • Unstable cardiovascular condition
  • Unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asker and Baerum Hospital, Medical Department

Rud, 1309, Norway

Location

Related Publications (8)

  • Ofstad AP, Johansen OE, Gullestad L, Birkeland KI, Orvik E, Fagerland MW, Urheim S, Aakhus S. Neutral impact on systolic and diastolic cardiac function of 2 years of intensified multi-intervention in type 2 diabetes: the randomized controlled Asker and Baerum Cardiovascular Diabetes (ABCD) study. Am Heart J. 2014 Sep;168(3):280-288.e2. doi: 10.1016/j.ahj.2014.03.026. Epub 2014 Jun 9.

    PMID: 25173538BACKGROUND

  • Ulimoen GR, Ofstad AP, Endresen K, Gullestad L, Johansen OE, Borthne A. Low-dose CT coronary angiography for assessment of coronary artery disease in patients with type 2 diabetes--a cross-sectional study. BMC Cardiovasc Disord. 2015 Nov 14;15:147. doi: 10.1186/s12872-015-0143-9.

    PMID: 26573616BACKGROUND

  • Johansen OE, Bjuro T, Endresen K, Blaasaas KG, Birkeland K, Aakhus S, Gullestad L. Heart rate adjustments and analysis of recovery patterns of ST-segment depression in type 2 diabetes. Int J Cardiol. 2008 Jun 23;127(1):129-32. doi: 10.1016/j.ijcard.2007.04.022. Epub 2007 May 25.

    PMID: 17532067BACKGROUND

  • Johansen OE, Birkeland KI, Orvik E, Flesland O, Wergeland R, Ueland T, Smith C, Endresen K, Aukrust P, Gullestad L. Inflammation and coronary angiography in asymptomatic type 2 diabetic subjects. Scand J Clin Lab Invest. 2007;67(3):306-16. doi: 10.1080/00365510601045088.

    PMID: 17454845BACKGROUND

  • Ofstad AP, Gullestad L, Orvik E, Aakhus S, Endresen K, Ueland T, Aukrust P, Fagerland MW, Birkeland KI, Johansen OE. Interleukin-6 and activin A are independently associated with cardiovascular events and mortality in type 2 diabetes: the prospective Asker and Baerum Cardiovascular Diabetes (ABCD) cohort study. Cardiovasc Diabetol. 2013 Aug 30;12:126. doi: 10.1186/1475-2840-12-126.

    PMID: 23987834BACKGROUND

  • Johansen OE, Gullestad L, Blaasaas KG, Orvik E, Birkeland KI. Effects of structured hospital-based care compared with standard care for Type 2 diabetes-The Asker and Baerum Cardiovascular Diabetes Study, a randomized trial. Diabet Med. 2007 Sep;24(9):1019-27. doi: 10.1111/j.1464-5491.2007.02198.x. Epub 2007 May 17.

    PMID: 17509068RESULT

  • Arora S, Ofstad AP, Ulimoen GR, Birkeland KI, Endresen K, Gullestad L, Johansen OE. Asymptomatic coronary artery disease in a Norwegian cohort with type 2 diabetes: a prospective angiographic study with intravascular ultrasound evaluation. Cardiovasc Diabetol. 2019 Mar 9;18(1):26. doi: 10.1186/s12933-019-0832-2.

    PMID: 30851727DERIVED

  • Ofstad AP, Ulimoen GR, Orvik E, Birkeland KI, Gullestad LL, Fagerland MW, Johansen OE. Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death. J Int Med Res. 2017 Oct;45(5):1535-1552. doi: 10.1177/0300060517707674. Epub 2017 Jun 19.

    PMID: 28627980DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery DiseaseDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Odd E Johansen, MD

    Asker and Baerum Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients were randomized to intensive care of standard care, outcomes were assessed by experts who where unaware of group allocation
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 24, 2005

Study Start

January 1, 2002

Primary Completion

April 1, 2006

Study Completion

May 29, 2012

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)