Type 2 DiabetesNCT01179165
Noninvasive Methods in Diagnosing Coronary Heart Disease in Diabetic Patients
An observational study of Type 2 Diabetes, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery disease and diagnostic yield of different non-invasive methods in patients with type 2 diabetes 40-75 years of age at examination. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diagnostic
- How many people
- 104 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes without known cardiac disease between 40 and 75 years of age
Who may be able to join
- Type 2 diabetes
- Age at diagnosis > 30 years
- Age at inclusion 40-75 years
Who cannot join
- Angina pectoris
- Coronary angiography/stress-test diagnostic of coronary artery disease last 3 years
- Previous myocardial infarction, coronary bypass operation/PCI or heart failure
- Clinical indication for stress -testing
- Active bronchospasm excluding use of adenosine
- eGFR < 30 ml/min/m2
- short estimated life expectancy due to cancer, chronic liver/renal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application in High Risk Groups of Recently Developed Noninvasive Methods in Diagnosing Coronary Heart Disease.A Community Based Study.
The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery disease and diagnostic yield of different non-invasive methods in patients with type 2 diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest, and perfusion after vasodilatation stress will be used in the study. A subpopulation will in addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise training.
- Conditions
- Type 2 Diabetes
- Being tested
- Diagnostic
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticOther
Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes age 40-75 | Only one diagnostic/observational group Receives: Other: Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac abnormalities/disease according to different examination modalities
Measured: at primary examination
Secondary outcomes (4)
Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.
Descriptive study; that is at baseline examination except substudy training group which will also be examined after 4 months of exercise training
Measured: at baseline
Relationship between CFR in LAD and forearm FMD
Relationship between CFR in LAD and forearm FMD before and after 4 months of exercise training in diabetics. Substudy
Measured: 4 months
Doppler echocardiographic findings related to clinical, laboratory and MRI findings
Special emphasis on new modalities as strain/strain rate at rest and stress. At baseline examination (no follow up)
Measured: at baseline
Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI
in exercise training group
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Volda Hospital
- Responsible party
- Sponsor
- Investigators
- Torstein L Hole, MD, PhD, Study chair, Norwegian University of Science and TechnologyRune Wiseth, Md, Phd, Study chair, Norwegian University of Science and TechnologySvein Hareide, MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179165
- Sponsor's protocol ID
- 83FU18-09
- Status last verified
- Mar 2017
- First submitted
- 30 Jul 2010
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application in High Risk Groups of Recently Developed Noninvasive Methods in Diagnosing Coronary Heart Disease.A Community Based Study.
- ClinicalTrials.gov ID
- NCT01179165
- Acronym / sponsor ID
- 83FU18-09
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Volda Hospital
- Study start
- Jan 2011 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the prevalence of cardiac disease/coronary artery disease and diagnostic yield of different non-invasive methods in patients with type 2 diabetes 40-75 years of age at examination. Exercise tests, Doppler echocardiographic examination with Tissue Velocity Imaging, stress Echocardiography, transthoracic Doppler of coronary arteries with coronary flow reserve, and cardiac MRI with late enhancement at rest, and perfusion after vasodilatation stress will be used in the study. A subpopulation will in addition measure forearm vasodilation(FMD) and CFR before and after 4 months of exercise training.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes age 40-75 | – | Other: DiagnosticOnly one diagnostic/observational group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes without known cardiac disease between 40 and 75 years of age
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Age at diagnosis > 30 years
- Age at inclusion 40-75 years
Key exclusion criteria (7 listed)
- Angina pectoris
- Coronary angiography/stress-test diagnostic of coronary artery disease last 3 years
- Previous myocardial infarction, coronary bypass operation/PCI or heart failure
- Clinical indication for stress -testing
- Active bronchospasm excluding use of adenosine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiagnosticDiagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI | Other | Type 2 diabetes age 40-75 |
Primary outcome
Prevalence of cardiac abnormalities/disease according to different examination modalities
Time frame: at primary examination
4 secondary outcomes
Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI.
Time frame: at baseline
Relationship between CFR in LAD and forearm FMD
Time frame: 4 months
Doppler echocardiographic findings related to clinical, laboratory and MRI findings
Time frame: at baseline
Feasibility of transthoracic coronary Doppler examination/Coronary Flow Reserve, and diagnostic yield related to MRI
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torstein L Hole, MD, PhD study chair
Norwegian University of Science and Technology
Rune Wiseth, Md, Phd study chair
Norwegian University of Science and Technology
Svein Hareide, MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Norwegian University of Science and Technology 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 3 inclusion and 7 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 8 Mar 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.
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?
Prevalence of cardiac abnormalities/disease according to different examination modalities (time frame: at primary examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2017.