Immune Profile and Complication Risk in Type 2 Diabetes (IMPACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00674271
First received: May 5, 2008
Last updated: November 3, 2011
Last verified: November 2011

May 5, 2008
November 3, 2011
May 2008
March 2011   (final data collection date for primary outcome measure)
Plaque burden in carotid arteries [ Time Frame: Individual ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00674271 on ClinicalTrials.gov Archive Site
  • Serum levels of pattern recognition molecules [ Time Frame: Individual ] [ Designated as safety issue: No ]
  • Genotyping genes for pattern recognition molecules [ Time Frame: Individual ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immune Profile and Complication Risk in Type 2 Diabetes
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.

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.

Observational
Not Provided
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, urine

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.

Diabetes Mellitus, Type 2
Not Provided
  • 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
Laugesen E, Høyem P, Stausbøl-Grøn B, Mikkelsen A, Thrysøe 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
May 2018
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00674271
20080059
No
University of Aarhus
University of Aarhus
Aarhus University Hospital
Principal Investigator: Jens S Christiansen, Prof., MD Medical Department M, Aarhus University Hospital, Denmark
University of Aarhus
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP