Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Sponsor University of Aarhus
Collaborator Aarhus University Hospital
Start date May 2008
End date March 2011
Trial size 200 participants
Trial identifier NCT00674271, 20080059

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Plaque burden in carotid arteries
time frame: Individual

Secondary Outcomes

Measure
Serum levels of pattern recognition molecules
time frame: Individual
Genotyping genes for pattern recognition molecules
time frame: Individual

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Immune Profile and Complications Risk in Type 2 Diabetes
Principal investigator Jens S Christiansen, Prof., MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by University of Aarhus.