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Type 2 Diabetes MellitusPhase 4NCT00133718

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

A Phase 4 study testing Combined lifestyle intervention and optimisation of pharmacological treatment in people with Type 2 Diabetes Mellitus, run by Asker & Baerum Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Combined lifestyle intervention and optimisation of pharmacological treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteNorway
Study dates
Jan 2002to 29 May 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Asker and Baerum Hospital, Medical Department

    Rud, 1309

Other trials in Norway

About this study

Official title: 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.
Read the 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.

Being tested
Combined lifestyle intervention and optimisation of pharmacological treatment
Keywords
Type 2 diabetes mellitus, Cardiovascular, Coronary artery disease, Glycemic control, Treatment, Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2, Coronary Artery Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined lifestyle intervention and optimisation of pharmacological treatmentDrug

    Also called Combination of drugs (predefined) to reach treatment targets

    1. 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)
    2. standard care
Study groups in NCT00133718
Study groupRoleWhat they receive
Structured multi interventionOtherStructured multi intervention to reach predefined glycemic and blood pressure goals as well as activity and weight goal
Receives: Drug: Combined lifestyle intervention and optimisation of pharmacological treatment
Standard of careOtherStandard care with or without structured care according to national guidelines
Receives: Drug: Combined lifestyle intervention and optimisation of pharmacological treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in 10-year absolute CHD risk

    Measured: 2-year

Secondary outcomes (4)

  1. Effects on cardiovascular events

    Measured: 5-year

  2. Effects on hospitalisations

    Measured: 5-year

  3. Effects on CV risk markers (HbA1c, lipids, blood pressure, inflammation, etc)

    Measured: 2 years and 5 years

  4. Effects on health related quality of life

    Measured: 2 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startJan 2002
  3. Primary completionApr 2006
  4. Study completion29 May 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00133718
Sponsor's protocol ID
ABCD-study
Status last verified
Jan 2017
First submitted
23 Aug 2005
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25173538

  • 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.

    PubMed 26573616

  • 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.

    PubMed 17532067

  • 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.

    PubMed 17454845

  • 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.

    PubMed 23987834

  • 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.

    PubMed 17509068

  • 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.

    PubMed 30851727

  • 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.

    PubMed 28627980

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combined lifestyle intervention and optimisation of pharmacological treatment in people with Type 2 Diabetes Mellitus, run by Asker & Baerum Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in 10-year absolute CHD risk (time frame: 2-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00133718, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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