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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00674271
Other study ID # 20080059
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 5, 2008
Last updated November 3, 2011
Start date May 2008
Est. completion date May 2018

Study information

Verified date November 2011
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical 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.

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.


Description:

Aim: The primary aims of the project are:

1. 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.

2. 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.

3. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date May 2018
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Medical Department M, Aarhus University Hospital Aarhus C

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque burden in carotid arteries Individual No
Secondary Serum levels of pattern recognition molecules Individual No
Secondary Genotyping genes for pattern recognition molecules Individual No
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