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| Sponsors and Collaborators: |
University of Aarhus Aarhus University Hospital |
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| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00674271 |
Purpose
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.
| Condition |
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Diabetes Mellitus, Type 2 |
| Study Type: | Observational |
| Official Title: | Immune Profile and Complications Risk in Type 2 Diabetes |
Whole blood, urine
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
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Controls
100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender
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Aim: The primary aims of the project are:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Both:
Exclusion Criteria:
Both:
Contacts and Locations| Contact: Pernille H Høyem, M.D. | +4589492035 | |
| Contact: Troels K Hansen, M.D., PH.D. | +4589492057 |
| Denmark | |
| Medical Department M, Aarhus University Hospital | Recruiting |
| Aarhus C, Denmark, 8000 | |
| Contact: Pernille H Høyem, MD +4589492035 | |
| Contact: Troels K Hansen, MD, PhD +4589492057 | |
| Principal Investigator: | Jens S Christiansen, Prof., MD | Medical Department M, Aarhus University Hospital, Denmark |
More Information
| Responsible Party: | Medical Department M, Aarhus University Hospital ( MD Professor DMSc Jens Sandahl Christiansen ) |
| Study ID Numbers: | 20080059 |
| Study First Received: | May 5, 2008 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00674271 History of Changes |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics |
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Diabetes Mellitus, Type 2 Mannose-Binding lectin Toll-Like Receptors Atherosclerosis |
Carotid Arteries Diabetes Complications Diabetic Angiopathies |
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Atherosclerosis Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Diabetes Complications Diabetic Angiopathies |
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Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
