Diabetes Mellitus, Type 2NCT02684331
CMR in Type 2 Diabetes Mellitus Patients
An observational study of Diabetes Mellitus, Type 2 and Heart Disease, run by Slagelse Hospital at 1 site in Denmark.
Trial summary
The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heart Disease
- What is being tested?
- Cardiac Magnetic Resonance Imaging (CMR), Echocardiography and Bood samples
- How many people
- 296 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jul 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 T2DM patients, with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will be divided into groups depending on their diabetes complication status. Individual groups of patients with fx. +/- retinopathy, +/- autonomous neuropathy, +/- hypertension, normo-/mikro-/makroalbuminuria will be compared.
Who may be able to join
- Male or female patient fully capable of informed consent
- Informed consent
- T2DM
- Age 18-80 (both years included)
Who cannot join
- Contraindications to CMR (pacemakers/ICD-units, cochlear implants)
- Lack of consent
- Atrial fibrillation
- eGFR < 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study)
- Women of childbearing potential who are not on acceptable contraception
- Severe claustrophobia (only contraindication for CMR but can undergo echocardiography and other examinations)
- Contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure
- Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The diabetes outpatient clinic, Slagelse Hospital, Denmark
Slagelse, 4200
About this study
Official title: Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction
The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.
This study project sets out to answer the following hypotheses:
- Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR.
- Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.
- Conditions
- Diabetes Mellitus, Type 2, Heart Disease
- Being tested
- Cardiac Magnetic Resonance Imaging (CMR), Echocardiography, Bood samples
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance Imaging (CMR)Other
An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping.
EchocardiographyOther
Standard measurements and strain.
Bood samplesOther
HbA1c, Glucose, Hgb, Creatinin, Sodium, Potassium, Total cholesterol, LDL cholesterol, HDL cholesterol, Free fatty acids, ALAT, Urinary albumin, NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3
| Study group | Role | What they receive |
|---|---|---|
| T2DM | Not described Receives: Other: Cardiac Magnetic Resonance Imaging (CMR); Other: Echocardiography; Other: Bood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
On CMR; left ventricle peak filling rate (ml/s)
Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
Measured: Cross-sectional so at baseline
On CMR, LV myocardial perfusion
Including measurements at rest and with Adenosin stress
Measured: Cross-sectional so at baseline
On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function
Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
Measured: Cross-sectional so at baseline
Secondary outcomes (3)
Echocardiography
Systolic function
Measured: Cross-sectional so at baseline
Blod samples
NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3
Measured: Cross-sectional so at baseline
Echocardiography
Diastolic function
Measured: Cross-sectional so at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annemie Stege Bojer, Slagelse Hospital
- Investigators
- Martin H Soerensen, DM, Principal investigator, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684331
- Sponsor's protocol ID
- SJ-490
- Status last verified
- Sep 2019
- First submitted
- 8 Feb 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bojer AS, Sorensen MH, Madsen SH, Broadbent DA, Plein S, Gaede P, Madsen PL. The independent association of myocardial extracellular volume and myocardial blood flow with cardiac diastolic function in patients with type 2 diabetes: a prospective cross-sectional cohort study. Cardiovasc Diabetol. 2023 Mar 31;22(1):78. doi: 10.1186/s12933-023-01804-9.
PubMed 37004049Bojer AS, Sorensen MH, Vejlstrup N, Goetze JP, Gaede P, Madsen PL. Distinct non-ischemic myocardial late gadolinium enhancement lesions in patients with type 2 diabetes. Cardiovasc Diabetol. 2020 Oct 22;19(1):184. doi: 10.1186/s12933-020-01160-y.
PubMed 33092588Sorensen MH, Bojer AS, Jorgensen NR, Broadbent DA, Plein S, Madsen PL, Gaede P. Fibroblast growth factor-23 is associated with imaging markers of diabetic cardiomyopathy and anti-diabetic therapeutics. Cardiovasc Diabetol. 2020 Sep 30;19(1):158. doi: 10.1186/s12933-020-01135-z.
PubMed 32998751Sorensen MH, Bojer AS, Pontoppidan JRN, Broadbent DA, Plein S, Madsen PL, Gaede P. Reduced Myocardial Perfusion Reserve in Type 2 Diabetes Is Caused by Increased Perfusion at Rest and Decreased Maximal Perfusion During Stress. Diabetes Care. 2020 Jun;43(6):1285-1292. doi: 10.2337/dc19-2172. Epub 2020 Mar 19.
PubMed 32193248Sorensen MH, Bojer AS, Broadbent DA, Plein S, Madsen PL, Gaede P. Cardiac perfusion, structure, and function in type 2 diabetes mellitus with and without diabetic complications. Eur Heart J Cardiovasc Imaging. 2020 Aug 1;21(8):887-895. doi: 10.1093/ehjci/jez266.
PubMed 31642902
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction
- ClinicalTrials.gov ID
- NCT02684331
- Acronym / sponsor ID
- SJ-490
- Conditions
- Diabetes Mellitus, Type 2, Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 18 Feb 2016 (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 study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.
This study project sets out to answer the following hypotheses:
- Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR.
- Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM | – | Other: Cardiac Magnetic Resonance Imaging (CMR), Other: Echocardiography, Other: Bood samples |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 T2DM patients, with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will be divided into groups depending on their diabetes complication status. Individual groups of patients with fx. +/- retinopathy, +/- autonomous neuropathy, +/- hypertension, normo-/mikro-/makroalbuminuria will be compared.
Key inclusion criteria (4 listed)
- Male or female patient fully capable of informed consent
- Informed consent
- T2DM
- Age 18-80 (both years included)
Key exclusion criteria (8 listed)
- Contraindications to CMR (pacemakers/ICD-units, cochlear implants)
- Lack of consent
- Atrial fibrillation
- eGFR < 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study)
- Women of childbearing potential who are not on acceptable contraception
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 |
|---|---|---|
| Cardiac Magnetic Resonance Imaging (CMR)An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping. | Other | T2DM |
| EchocardiographyStandard measurements and strain. | Other | T2DM |
| Bood samplesHbA1c, Glucose, Hgb, Creatinin, Sodium, Potassium, Total cholesterol, LDL cholesterol, HDL cholesterol, Free fatty acids, ALAT, Urinary albumin, NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3 | Other | T2DM |
Primary outcome
On CMR; left ventricle peak filling rate (ml/s)
Time frame: Cross-sectional so at baseline
Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
On CMR, LV myocardial perfusion
Time frame: Cross-sectional so at baseline
Including measurements at rest and with Adenosin stress
On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function
Time frame: Cross-sectional so at baseline
Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
3 secondary outcomes
Echocardiography
Time frame: Cross-sectional so at baseline
Blod samples
Time frame: Cross-sectional so at baseline
Echocardiography
Time frame: Cross-sectional so at baseline
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 19 Sep 2019.
- Derived from this study: PubMed 37004049Bojer AS, Sorensen MH, Madsen SH, Broadbent DA, Plein S, Gaede P, Madsen PL. The independent association of myocardial extracellular volume and myocardial blood flow with cardiac diastolic function in patients with type 2 diabetes: a prospective cross-sectional cohort study. Cardiovasc Diabetol. 2023 Mar 31;22(1):78. doi: 10.1186/s12933-023-01804-9.
- Derived from this study: PubMed 33092588Bojer AS, Sorensen MH, Vejlstrup N, Goetze JP, Gaede P, Madsen PL. Distinct non-ischemic myocardial late gadolinium enhancement lesions in patients with type 2 diabetes. Cardiovasc Diabetol. 2020 Oct 22;19(1):184. doi: 10.1186/s12933-020-01160-y.
- Derived from this study: PubMed 32998751Sorensen MH, Bojer AS, Jorgensen NR, Broadbent DA, Plein S, Madsen PL, Gaede P. Fibroblast growth factor-23 is associated with imaging markers of diabetic cardiomyopathy and anti-diabetic therapeutics. Cardiovasc Diabetol. 2020 Sep 30;19(1):158. doi: 10.1186/s12933-020-01135-z.
- Derived from this study: PubMed 32193248Sorensen MH, Bojer AS, Pontoppidan JRN, Broadbent DA, Plein S, Madsen PL, Gaede P. Reduced Myocardial Perfusion Reserve in Type 2 Diabetes Is Caused by Increased Perfusion at Rest and Decreased Maximal Perfusion During Stress. Diabetes Care. 2020 Jun;43(6):1285-1292. doi: 10.2337/dc19-2172. Epub 2020 Mar 19.
- Derived from this study: PubMed 31642902Sorensen MH, Bojer AS, Broadbent DA, Plein S, Madsen PL, Gaede P. Cardiac perfusion, structure, and function in type 2 diabetes mellitus with and without diabetic complications. Eur Heart J Cardiovasc Imaging. 2020 Aug 1;21(8):887-895. doi: 10.1093/ehjci/jez266.
- Individual participant dataSharing planned: No
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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.
Martin H Soerensen, DM principal investigator
Slagelse Hospital
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 Diabetes Mellitus, Type 2 and Heart Disease, run by Slagelse Hospital at 1 site in Denmark.
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 4 inclusion and 8 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 19 Sep 2019. 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 Denmark. 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?
On CMR; left ventricle peak filling rate (ml/s) (time frame: Cross-sectional so at baseline). The study lists 3 primary outcomes in all. 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 NCT02684331, which also lists 5 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 19 Sep 2019.