Diabetes Mellitus, Type 2IMPACTNCT00674271
Immune Profile and Complication Risk in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the relation between individual differences in pattern recognition molecules (PRM's) in the innate immune system and the prevalence and development of vascular complications in patients with type 2 diabetes. 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
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to May 2018
- 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 newly diagnosed (<5 years since diagnosis) type 2 diabetes referred from general practitioners to Medical Department M, Aarhus University Hospital, Denmark. 100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender.
Who may be able to join
- Diabetics: Newly diagnosed (<5 years since diagnoses) type 2 diabetes due to national diagnosis criteria
- Controls: No diabetes or prediabetes in oral glucose tolerance test
- Both:
- Age > 18 years
- Signed informed consent
Who cannot join
- Both:
- Pacemaker or other magnetic materials in the body
- Severe claustrophobia
- Pregnancy/lactation
- Cancer - former or current
- Acute or chronic infection
- Dialysis-dependent kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Profile and Complications Risk in Type 2 Diabetes
The aim of this study is to investigate the relation between individual differences in pattern recognition molecules (PRM's) in the innate immune system and the prevalence and development of vascular complications in patients with type 2 diabetes.
This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate immune system contributes to a chronic low grade inflammation in diabetic patients. Variation in PRM's - at the genome, proteome as well as the functional level - are therefore associated with the degree of chronic low grade inflammation, and probably also with the prevalence of vascular complications.
Read the detailed description
Aim: The primary aims of the project are:
- By use of advanced magnetic resonance imaging to characterize the prevalence of atherosclerosis in the carotid arteries in patients with newly diagnosed type 2 diabetes.
- To investigate if individual differences in the innate immune system contributes to the prevalence and development of cardiovascular disease in patients with type 2 diabetes.
- To prospectively observe the cardiovascular morbidity and mortality in a cohort of patients with type 2 diabetes seen in the light of the obtained baseline characteristics.
Background: Type 2 diabetes is a very common disease in the western world. Patients with type 2 diabetes are at risk of a number of complications, including macroangiopathy which involves an accelerated atherosclerosis, that causes most of the increased mortality and morbidity in type 2 diabetics. Mounting evidence suggests that development of vascular complications is associated to a chronic low grad inflammation in type 2 diabetes. Individual differences in the innate immune system might contribute to this chronic low grade inflammation as it has become apparent that in some situations - as after tissue ischemia or in diabetes - a change in the body's own cell glycosylations occurs, which leads to increased affinity of PRM's. This study will focus primarily on two families of PRM's: Collectins and Toll-like receptors.
Methods: The study consists of a prospective observational cohort study of 100 newly diagnosed type 2 diabetic patients with continuous 2-year clinical follow-up and a register-based follow-up of morbidity and mortality study after 5 and 10 years. Furthermore 100 healthy control subjects will be included. Baseline data will represent a independent cross-sectional study of the relationship between the innate immune system, glycemic control and the presence of atherosclerosis in the carotid arteries in newly diagnosed type 2 diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Mannose-Binding lectin, Toll-Like Receptors, Atherosclerosis, Carotid Arteries, Diabetes Complications, Diabetic Angiopathies
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis, Diabetes Complications, Diabetic Angiopathies
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 |
|---|---|---|
| Diabetics | 100 patients with newly diagnosed (<5 years since diagnosis) type 2 diabetes referred from general practitioners to Medical Department M, Aarhus University Hospital, Denmark. | |
| Controls | 100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque burden in carotid arteries
Measured: Individual
Secondary outcomes (2)
Serum levels of pattern recognition molecules
Measured: Individual
Genotyping genes for pattern recognition molecules
Measured: Individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2011
- Study completionMay 2018 (estimated)
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.
- More trials run by University of AarhusThe 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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jens S Christiansen, Prof., MD, Principal investigator, Medical Department M, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674271
- Sponsor's protocol ID
- 20080059
- Acronym
- IMPACT
- Status last verified
- Nov 2011
- First submitted
- 5 May 2008
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Laugesen E, Hoyem P, Fleischer J, Kumarathas I, Knudsen ST, Hansen KW, Christiansen JS, Hansen TK, Poulsen PL. Reduced Subendocardial Viability Ratio Is Associated With Unfavorable Cardiovascular Risk Profile in Women With Short Duration of Type 2 Diabetes. Am J Hypertens. 2016 Oct;29(10):1165-72. doi: 10.1093/ajh/hpw066. Epub 2016 Jul 12.
PubMed 27405963Funck KL, Laugesen E, Hoyem P, Fleischer J, Cichosz SL, Christiansen JS, Hansen TK, Poulsen PL. Low Physical Activity Is Associated With Increased Arterial Stiffness in Patients Recently Diagnosed With Type 2 Diabetes. Am J Hypertens. 2016 Jul;29(7):882-8. doi: 10.1093/ajh/hpv197. Epub 2015 Dec 28.
PubMed 26714500Fleischer J, Lebech Cichosz S, Hoeyem P, Laugesen E, Loegstrup Poulsen P, Sandahl Christiansen J, Tarnow L, Hansen TK. Glycemic variability is associated with reduced cardiac autonomic modulation in women with type 2 diabetes. Diabetes Care. 2015 Apr;38(4):682-8. doi: 10.2337/dc14-0654. Epub 2015 Jan 8.
PubMed 25573884Laugesen 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 23866070Laugesen 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 23129135
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profile and Complications Risk in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00674271
- Acronym / sponsor ID
- IMPACT / 20080059
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Mannose-Binding lectin, Toll-Like Receptors, Atherosclerosis, Carotid Arteries, Diabetes Complications, Diabetic Angiopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- May 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 7 May 2008 (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 aim of this study is to investigate the relation between individual differences in pattern recognition molecules (PRM's) in the innate immune system and the prevalence and development of vascular complications in patients with type 2 diabetes.
This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate immune system contributes to a chronic low grade inflammation in diabetic patients. Variation in PRM's - at the genome, proteome as well as the functional level - are therefore associated with the degree of chronic low grade inflammation, and probably also with the prevalence of vascular complications.
Detailed description
Aim: The primary aims of the project are:
- By use of advanced magnetic resonance imaging to characterize the prevalence of atherosclerosis in the carotid arteries in patients with newly diagnosed type 2 diabetes.
- To investigate if individual differences in the innate immune system contributes to the prevalence and development of cardiovascular disease in patients with type 2 diabetes.
- To prospectively observe the cardiovascular morbidity and mortality in a cohort of patients with type 2 diabetes seen in the light of the obtained baseline characteristics.
Background: Type 2 diabetes is a very common disease in the western world. Patients with type 2 diabetes are at risk of a number of complications, including macroangiopathy which involves an accelerated atherosclerosis, that causes most of the increased mortality and morbidity in type 2 diabetics. Mounting evidence suggests that development of vascular complications is associated to a chronic low grad inflammation in type 2 diabetes. Individual differences in the innate immune system might contribute to this chronic low grade inflammation as it has become apparent that in some situations - as after tissue ischemia or in diabetes - a change in the body's own cell glycosylations occurs, which leads to increased affinity of PRM's. This study will focus primarily on two families of PRM's: Collectins and Toll-like receptors.
Methods: The study consists of a prospective observational cohort study of 100 newly diagnosed type 2 diabetic patients with continuous 2-year clinical follow-up and a register-based follow-up of morbidity and mortality study after 5 and 10 years. Furthermore 100 healthy control subjects will be included. Baseline data will represent a independent cross-sectional study of the relationship between the innate immune system, glycemic control and the presence of atherosclerosis in the carotid arteries in newly diagnosed type 2 diabetic patients.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics | – | –100 patients with newly diagnosed (<5 years since diagnosis) type 2 diabetes referred from general practitioners to Medical Department M, Aarhus University Hospital, Denmark. |
| Controls | – | –100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with newly diagnosed (<5 years since diagnosis) type 2 diabetes referred from general practitioners to Medical Department M, Aarhus University Hospital, Denmark. 100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender.
Key inclusion criteria (5 listed)
- Diabetics: Newly diagnosed (<5 years since diagnoses) type 2 diabetes due to national diagnosis criteria
- Controls: No diabetes or prediabetes in oral glucose tolerance test
- Age > 18 years
- Signed informed consent
Key exclusion criteria (7 listed)
- Pacemaker or other magnetic materials in the body
- Severe claustrophobia
- Pregnancy/lactation
- Cancer - former or current
- Acute or chronic infection
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
Plaque burden in carotid arteries
Time frame: Individual
2 secondary outcomes
Serum levels of pattern recognition molecules
Time frame: Individual
Genotyping genes for pattern recognition molecules
Time frame: Individual
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Derived from this study: PubMed 27405963Laugesen E, Hoyem P, Fleischer J, Kumarathas I, Knudsen ST, Hansen KW, Christiansen JS, Hansen TK, Poulsen PL. Reduced Subendocardial Viability Ratio Is Associated With Unfavorable Cardiovascular Risk Profile in Women With Short Duration of Type 2 Diabetes. Am J Hypertens. 2016 Oct;29(10):1165-72. doi: 10.1093/ajh/hpw066. Epub 2016 Jul 12.
- Derived from this study: PubMed 26714500Funck KL, Laugesen E, Hoyem P, Fleischer J, Cichosz SL, Christiansen JS, Hansen TK, Poulsen PL. Low Physical Activity Is Associated With Increased Arterial Stiffness in Patients Recently Diagnosed With Type 2 Diabetes. Am J Hypertens. 2016 Jul;29(7):882-8. doi: 10.1093/ajh/hpv197. Epub 2015 Dec 28.
- Derived from this study: PubMed 25573884Fleischer J, Lebech Cichosz S, Hoeyem P, Laugesen E, Loegstrup Poulsen P, Sandahl Christiansen J, Tarnow L, Hansen TK. Glycemic variability is associated with reduced cardiac autonomic modulation in women with type 2 diabetes. Diabetes Care. 2015 Apr;38(4):682-8. doi: 10.2337/dc14-0654. Epub 2015 Jan 8.
- Derived from this study: 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 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.
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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.
Jens S Christiansen, Prof., MD principal investigator
Medical Department M, Aarhus University Hospital, Denmark
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, run by University of Aarhus 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 5 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: status not confirmed, as of the sponsor's last update on 4 Nov 2011. 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?
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?
Plaque burden in carotid arteries (time frame: Individual). 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 NCT00674271, 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 4 Nov 2011.