the study aims to answer the following question:are components of innate immunity in general, and the complementsystem in particular, correlated with and usefull as predictors for the occurrence of macro- and/or microvascular complications in a high…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- prevalence / progression nephropathy
- prevalence retinopathy
- prevalence ischemic heart disease
- prevalence peripheral vascular disease
- prevalence cerebral vascular accidents
- intima media thickness of the carotid artery
- pulse wave velocity analysis
Secondary outcome
no
Background summary
South-Asian immigrants in a western society have an increased risk of
developing diabetes and associated cardiovascular complications. Beside
traditional risk factors like glycaemic control, hypertension, lipid
disturbances and smoking, there is an increasing body of evidence that the
complement system, belonging to innnate immunity, is involved in the
pathogenesis / progression of these vascular complications. Complementproducts
have been detected in kidneys of diabetic patients and in atherosclerotic
plaques. Complement activation products have been detected in the urine of
patients with diabetic nephropathy. More recently, an association between
serumlevels of MBL (Mannan, Binding Lectin, the recognitionmolecule of the
lectin pathway of complement activation) and diabetes was reported. MBL levels
were increased in diabetic persons compared to healthy control persons. In
addition, the serum MBL level were positively correlated with the incidence of
nephropathy and cardiovascular disease. In type 2 diabetics a positive
correlation between MBL levels and (cardiovascular) mortality was also found.
Mutations in the factor H gene, an inhibitor of the complementsystem, have
recently been associated with an increased incidence of ischemic heart disease.
Study objective
the study aims to answer the following question:are components of innate
immunity in general, and the complementsystem in particular, correlated with
and usefull as predictors for the occurrence of macro- and/or microvascular
complications in a high-risk population of type II diabetic South Asian
immigrants?
Study design
It is a follow-up study of the previously conducted Hindinef study. This study
included South-Asian immigrants (both diabetic and non-diabetic) and was
performed between 1998 and 2000. Clinical information as well as blood- and
urine samples have been collected from all these persons. We will study innate
immunity in these "baseline"samples. Next we aim to recall all the diabetic
subjects and score the progression of diabetic nephropathy and the incidence of
vascular complications. We will investigate the association between
immunological parameters (complement activation products, leucocyte activation,
cytokine profiles) and the progression of complications (nephropathy,
retinopathy, atherosclerosis).
Study burden and risks
the testperson visits our outpatient clinic. During this visit we perform a
questionnaire - which has been sent to the homeaddress-, a brief physical
examination, venapuncture, sampling of urine, EKG and fundusphotography. In
this visit, permission is asked for a second visit in which the carotid artery
intima media thickness is measured and pulse wave velocity is analysed
albinusdreef 2
2300 RC Leiden
Nederland
albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
diabetes type II
Exclusion criteria
geen
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL15586.058.06 |