Diabetes Mellitus, Type 2NCT02001532
Arterial Stiffness and Complication Risk in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Diabetes Complications, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Background The prevalence and incidence of type 2 diabetes is increasing globally. A common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Jul 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients with type 2 diabetes (cases) were enrolled from the outpatient clinic of the Department of Endocrinology, Aarhus University Hospital between 2008-11. 100 sex and age-matched healthy controls were recruited in the same time period through the local press.
Who may be able to join
- 18 years of age
- Diabetes, type 2, diagnosed within 5 years from baseline (cases)
Who cannot join
- Non-diagnosed diabetes (healthy controls)
- Acute or chronic infectious diseases
- Kidney failure (requiring dialysis)
- Pregnancy/breastfeeding
- Prior or concomitant cancer disease
- Contraindication for MRI (claustrophobia, magnetic implants or bodyweight above 120kg)
- Contraindication for CT (estimated glomerular filtration rate < 50 ml/min, Body Mass Index > 35 kg/m2, heart arrhythmia, heart failure, aorta stenosis, contraindications for beta blockage or nitroglycerin or failure to cooperate)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Endocrinology, Aarhus University Hospital
Aarhus, 8000
About this study
Background
The prevalence and incidence of type 2 diabetes is increasing globally. A common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical stages of macro-vascular disease are not yet available in a clinical setting.
Read more
Hypothesis
Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2.
Aim
The aim of the project is to investigate the association between arterial stiffness and the occurrence and development of vascular complications in patients with type 2 diabetes. Specifically we want to investigate:
- in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and
- in a longitudinal study, the predictive value of arterial stiffness on the development of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and nephropathy assessed by urine analysis.
Methods
The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100 age- and sex matched controls. The study participants were enrolled between 2008-2011 and extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned measurements. Furthermore, CT is used to investigate the coronary plaque burden of the participants (Agatston Score and Segment Involvement Score).
Results and Perspective
This project adds new insight into arterial stiffness as a predictor of the progression of micro- and macrovascular complications in patients with type 2 diabetes, and can potentially improve risk stratification and early strategies of intervention in this patient group.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies, Myocardial Infarction, Stroke, Vascular Stiffness, Pulse Wave Analysis
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes type 2 | Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up) | |
| Healthy controls | Sex and age-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter lesions (MRI)
A surrogate marker of the risk of stroke
Measured: 5 years
Albuminuria
A measure of kidney damage
Measured: 5 years
Segment Involvement Score (CT)
Measure of coronary plaques and a surrogate marker of ischemic heart disease.
Measured: Will be assessed within 3 weeks from enrollment
Agatston Score (CT)
Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease
Measured: Will be assessed within 3 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Per L Poulsen, MD, Ph.D., dr.med.sci, Principal investigator, Department of Medical Endocrinology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001532
- Sponsor's protocol ID
- 1-10-72-349-13
- Status last verified
- Feb 2016
- First submitted
- 21 Nov 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Laugesen E, Rossen NB, Hoyem P, Christiansen JS, Knudsen ST, Hansen KW, Hansen TK, Poulsen PL. Reproducibility of pulse wave analysis and pulse wave velocity in patients with type 2 diabetes. Scand J Clin Lab Invest. 2013 Aug;73(5):428-35. doi: 10.3109/00365513.2013.800578. Epub 2013 Jun 18.
PubMed 23777282Laugesen E, Hoyem P, Stausbol-Gron B, Mikkelsen A, Thrysoe S, Erlandsen M, Christiansen JS, Knudsen ST, Hansen KW, Kim WY, Hansen TK, Poulsen PL. Carotid-femoral pulse wave velocity is associated with cerebral white matter lesions in type 2 diabetes. Diabetes Care. 2013 Mar;36(3):722-8. doi: 10.2337/dc12-0942. Epub 2012 Nov 5.
PubMed 23129135Laugesen E, Hoyem P, Christiansen JS, Knudsen ST, Hansen KW, Argraves WS, Hansen TK, Poulsen PL, Rasmussen LM. Plasma levels of the arterial wall protein fibulin-1 are associated with carotid-femoral pulse wave velocity: a cross-sectional study. Cardiovasc Diabetol. 2013 Jul 18;12:107. doi: 10.1186/1475-2840-12-107.
PubMed 23866070Funck KL, Laugesen E, Ovrehus K, Jensen JM, Norgaard BL, Dey D, Hansen TK, Poulsen PL. Increased high-risk coronary plaque burden is associated with arterial stiffness in patients with type 2 diabetes without clinical signs of coronary artery disease: a computed tomography angiography study. J Hypertens. 2017 Jun;35(6):1235-1243. doi: 10.1097/HJH.0000000000001308.
PubMed 28441695
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness and Complication Risk in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02001532
- Acronym / sponsor ID
- 1-10-72-349-13
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies, Myocardial Infarction, Stroke, Vascular Stiffness, Pulse Wave Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Dec 2013 (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.
Background
The prevalence and incidence of type 2 diabetes is increasing globally. A common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical stages of macro-vascular disease are not yet available in a clinical setting.
Hypothesis
Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2.
Aim
The aim of the project is to investigate the association between arterial stiffness and the occurrence and development of vascular complications in patients with type 2 diabetes. Specifically we want to investigate:
- in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and
- in a longitudinal study, the predictive value of arterial stiffness on the development of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and nephropathy assessed by urine analysis.
Methods
The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100 age- and sex matched controls. The study participants were enrolled between 2008-2011 and extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned measurements. Furthermore, CT is used to investigate the coronary plaque burden of the participants (Agatston Score and Segment Involvement Score).
Results and Perspective
This project adds new insight into arterial stiffness as a predictor of the progression of micro- and macrovascular complications in patients with type 2 diabetes, and can potentially improve risk stratification and early strategies of intervention in this patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes type 2 | – | –Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up) |
| Healthy controls | – | –Sex and age-matched healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with type 2 diabetes (cases) were enrolled from the outpatient clinic of the Department of Endocrinology, Aarhus University Hospital between 2008-11. 100 sex and age-matched healthy controls were recruited in the same time period through the local press.
Key inclusion criteria (2 listed)
- 18 years of age
- Diabetes, type 2, diagnosed within 5 years from baseline (cases)
Key exclusion criteria (7 listed)
- Non-diagnosed diabetes (healthy controls)
- Acute or chronic infectious diseases
- Kidney failure (requiring dialysis)
- Pregnancy/breastfeeding
- Prior or concomitant cancer disease
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
White matter lesions (MRI)
Time frame: 5 years
A surrogate marker of the risk of stroke
Albuminuria
Time frame: 5 years
A measure of kidney damage
Segment Involvement Score (CT)
Time frame: Will be assessed within 3 weeks from enrollment
Measure of coronary plaques and a surrogate marker of ischemic heart disease.
Agatston Score (CT)
Time frame: Will be assessed within 3 weeks from enrollment
Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease
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 26 Oct 2017.
- Background: PubMed 23777282Laugesen E, Rossen NB, Hoyem P, Christiansen JS, Knudsen ST, Hansen KW, Hansen TK, Poulsen PL. Reproducibility of pulse wave analysis and pulse wave velocity in patients with type 2 diabetes. Scand J Clin Lab Invest. 2013 Aug;73(5):428-35. doi: 10.3109/00365513.2013.800578. Epub 2013 Jun 18.
- Results publication: PubMed 23129135Laugesen E, Hoyem P, Stausbol-Gron B, Mikkelsen A, Thrysoe S, Erlandsen M, Christiansen JS, Knudsen ST, Hansen KW, Kim WY, Hansen TK, Poulsen PL. Carotid-femoral pulse wave velocity is associated with cerebral white matter lesions in type 2 diabetes. Diabetes Care. 2013 Mar;36(3):722-8. doi: 10.2337/dc12-0942. Epub 2012 Nov 5.
- Results publication: PubMed 23866070Laugesen E, Hoyem P, Christiansen JS, Knudsen ST, Hansen KW, Argraves WS, Hansen TK, Poulsen PL, Rasmussen LM. Plasma levels of the arterial wall protein fibulin-1 are associated with carotid-femoral pulse wave velocity: a cross-sectional study. Cardiovasc Diabetol. 2013 Jul 18;12:107. doi: 10.1186/1475-2840-12-107.
- Derived from this study: PubMed 28441695Funck KL, Laugesen E, Ovrehus K, Jensen JM, Norgaard BL, Dey D, Hansen TK, Poulsen PL. Increased high-risk coronary plaque burden is associated with arterial stiffness in patients with type 2 diabetes without clinical signs of coronary artery disease: a computed tomography angiography study. J Hypertens. 2017 Jun;35(6):1235-1243. doi: 10.1097/HJH.0000000000001308.
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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.
Per L Poulsen, MD, Ph.D., dr.med.sci principal investigator
Department of Medical Endocrinology, Aarhus 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 Diabetes Mellitus, Type 2 and Diabetes Complications, run by Aarhus 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 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 26 Oct 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 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?
White matter lesions (MRI) (time frame: 5 years). The study lists 4 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 NCT02001532, which also lists 4 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 26 Oct 2017.