Type 2 Diabetes MellitusNCT00298844
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jan 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 20 years.
- Fasting C-peptide > 300 pmol/l.
Who cannot join
- Verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure < 30 mmHg).
- Suspected short lifespan because of malignant disease or end-stage kidney disease.
- Pregnancy or planned pregnancy during the study period.
- Body weight > 150 kg.
- Physical or mental disability not enabling participation in the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Mikael K. Poulsen, PhD student, +45 6541 4365, doc_mkp@hotmail.com
Jan Erik Henriksen, MD, PhD, +45 6541 4364, jan.erik.henriksen@ouh.fyns-amt.dk
About this study
Official title: Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient
The study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Macrovascular disease, Diastolic dysfunction, Intima media thickness, Single- photon emission computed tomography (SPECT)
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startJan 2006
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mikael K. Poulsen, PhD student, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298844
- Sponsor's protocol ID
- 021
- Status last verified
- Mar 2007
- First submitted
- 1 Mar 2006
- Last updated
- 23 Mar 2007
- Results posted
- No
Publications
Pedersen L, Nybo M, Poulsen MK, Henriksen JE, Dahl J, Rasmussen LM. Plasma calprotectin and its association with cardiovascular disease manifestations, obesity and the metabolic syndrome in type 2 diabetes mellitus patients. BMC Cardiovasc Disord. 2014 Dec 19;14:196. doi: 10.1186/1471-2261-14-196.
PubMed 25527236Poulsen MK, Dahl JS, Henriksen JE, Hey TM, Hoilund-Carlsen PF, Beck-Nielsen H, Moller JE. Left atrial volume index: relation to long-term clinical outcome in type 2 diabetes. J Am Coll Cardiol. 2013 Dec 24;62(25):2416-2421. doi: 10.1016/j.jacc.2013.08.1622. Epub 2013 Sep 24.
PubMed 24076532Poulsen MK, Nybo M, Dahl J, Hosbond S, Poulsen TS, Johansen A, Hoilund-Carlsen PF, Beck-Nielsen H, Rasmussen LM, Henriksen JE. Plasma osteoprotegerin is related to carotid and peripheral arterial disease, but not to myocardial ischemia in type 2 diabetes mellitus. Cardiovasc Diabetol. 2011 Aug 12;10:76. doi: 10.1186/1475-2840-10-76.
PubMed 21838881Poulsen MK, Henriksen JE, Vach W, Dahl J, Moller JE, Johansen A, Gerke O, Haghfelt T, Hoilund-Carlsen PF, Beck-Nielsen H. Identification of asymptomatic type 2 diabetes mellitus patients with a low, intermediate and high risk of ischaemic heart disease: is there an algorithm? Diabetologia. 2010 Apr;53(4):659-67. doi: 10.1007/s00125-009-1646-7. Epub 2010 Jan 14.
PubMed 20225395Poulsen MK, Henriksen JE, Dahl J, Johansen A, Gerke O, Vach W, Haghfelt T, Hoilund-Carlsen PF, Beck-Nielsen H, Moller JE. Left ventricular diastolic function in type 2 diabetes mellitus: prevalence and association with myocardial and vascular disease. Circ Cardiovasc Imaging. 2010 Jan;3(1):24-31. doi: 10.1161/CIRCIMAGING.109.855510. Epub 2009 Oct 21.
PubMed 19846730Poulsen MK, Henriksen JE, Dahl J, Johansen A, Moller JE, Gerke O, Vach W, Haghfelt T, Beck-Nielsen H, Hoilund-Carlsen PF. Myocardial ischemia, carotid, and peripheral arterial disease and their interrelationship in type 2 diabetes patients. J Nucl Cardiol. 2009 Nov-Dec;16(6):878-87. doi: 10.1007/s12350-009-9118-5. Epub 2009 Aug 14.
PubMed 19685102
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient
- ClinicalTrials.gov ID
- NCT00298844
- Acronym / sponsor ID
- 021
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Macrovascular disease, Diastolic dysfunction, Intima media thickness, Single- photon emission computed tomography (SPECT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jan 2010 (estimated)
- First posted
- 3 Mar 2006 (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 aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: ≥ 20 years.
- Fasting C-peptide > 300 pmol/l.
Key exclusion criteria (5 listed)
- Verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure < 30 mmHg).
- Suspected short lifespan because of malignant disease or end-stage kidney disease.
- Pregnancy or planned pregnancy during the study period.
- Body weight > 150 kg.
- Physical or mental disability not enabling participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2007.
- Derived from this study: PubMed 25527236Pedersen L, Nybo M, Poulsen MK, Henriksen JE, Dahl J, Rasmussen LM. Plasma calprotectin and its association with cardiovascular disease manifestations, obesity and the metabolic syndrome in type 2 diabetes mellitus patients. BMC Cardiovasc Disord. 2014 Dec 19;14:196. doi: 10.1186/1471-2261-14-196.
- Derived from this study: PubMed 24076532Poulsen MK, Dahl JS, Henriksen JE, Hey TM, Hoilund-Carlsen PF, Beck-Nielsen H, Moller JE. Left atrial volume index: relation to long-term clinical outcome in type 2 diabetes. J Am Coll Cardiol. 2013 Dec 24;62(25):2416-2421. doi: 10.1016/j.jacc.2013.08.1622. Epub 2013 Sep 24.
- Derived from this study: PubMed 21838881Poulsen MK, Nybo M, Dahl J, Hosbond S, Poulsen TS, Johansen A, Hoilund-Carlsen PF, Beck-Nielsen H, Rasmussen LM, Henriksen JE. Plasma osteoprotegerin is related to carotid and peripheral arterial disease, but not to myocardial ischemia in type 2 diabetes mellitus. Cardiovasc Diabetol. 2011 Aug 12;10:76. doi: 10.1186/1475-2840-10-76.
- Derived from this study: PubMed 20225395Poulsen MK, Henriksen JE, Vach W, Dahl J, Moller JE, Johansen A, Gerke O, Haghfelt T, Hoilund-Carlsen PF, Beck-Nielsen H. Identification of asymptomatic type 2 diabetes mellitus patients with a low, intermediate and high risk of ischaemic heart disease: is there an algorithm? Diabetologia. 2010 Apr;53(4):659-67. doi: 10.1007/s00125-009-1646-7. Epub 2010 Jan 14.
- Derived from this study: PubMed 19846730Poulsen MK, Henriksen JE, Dahl J, Johansen A, Gerke O, Vach W, Haghfelt T, Hoilund-Carlsen PF, Beck-Nielsen H, Moller JE. Left ventricular diastolic function in type 2 diabetes mellitus: prevalence and association with myocardial and vascular disease. Circ Cardiovasc Imaging. 2010 Jan;3(1):24-31. doi: 10.1161/CIRCIMAGING.109.855510. Epub 2009 Oct 21.
- Derived from this study: PubMed 19685102Poulsen MK, Henriksen JE, Dahl J, Johansen A, Moller JE, Gerke O, Vach W, Haghfelt T, Beck-Nielsen H, Hoilund-Carlsen PF. Myocardial ischemia, carotid, and peripheral arterial disease and their interrelationship in type 2 diabetes patients. J Nucl Cardiol. 2009 Nov-Dec;16(6):878-87. doi: 10.1007/s12350-009-9118-5. Epub 2009 Aug 14.
Related trials for Type 2 Diabetes Mellitus
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Mikael K. Poulsen, PhD student principal investigator
Odense University 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 Type 2 Diabetes Mellitus, run by Odense University 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Mar 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael K. Poulsen, PhD student (+45 65414365, doc_mkp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298844, which also lists 6 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 23 Mar 2007; AzTrials last refreshed its copy on 8 Nov 2026.