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
  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
Diabetes Mellitus, Type 2

Study Type: Observational
Official Title: Immune Profile and Complications Risk in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Plaque burden in carotid arteries [ Time Frame: Individual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Whole blood, urine


Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: May 2018
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674271

Locations
Denmark
Medical Department M, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Jens S Christiansen, Prof., MD Medical Department M, Aarhus University Hospital, Denmark
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00674271     History of Changes
Other Study ID Numbers: 20080059
Study First Received: May 5, 2008
Last Updated: November 3, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Diabetes Mellitus, Type 2
Mannose-Binding lectin
Toll-Like Receptors
Atherosclerosis
Carotid Arteries
Diabetes Complications
Diabetic Angiopathies

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014