Arterial Stiffness and Complication Risk in Type 2 Diabetes
The prevalence and incidence of type 2 diabetes is increasing globally. A common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical stages of macro-vascular disease are not yet available in a clinical setting.
Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2.
The aim of the project is to investigate the association between arterial stiffness and the occurrence and development of vascular complications in patients with type 2 diabetes. Specifically we want to investigate:
- in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and
- in a longitudinal study, the predictive value of arterial stiffness on the development of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and nephropathy assessed by urine analysis.
The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100 age- and sex matched controls. The study participants were enrolled between 2008-2011 and extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned measurements. Furthermore, CT is used to investigate the coronary plaque burden of the participants (Agatston Score and Segment Involvement Score).
Results and Perspective
This project adds new insight into arterial stiffness as a predictor of the progression of micro- and macrovascular complications in patients with type 2 diabetes, and can potentially improve risk stratification and early strategies of intervention in this patient group.
Diabetes Mellitus, Type 2
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Arterial Stiffness and Complication Risk in Type 2 Diabetes|
- White matter lesions (MRI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]A surrogate marker of the risk of stroke
- Albuminuria [ Time Frame: 5 years ] [ Designated as safety issue: No ]A measure of kidney damage
- Segment Involvement Score (CT) [ Time Frame: Will be assessed within 3 weeks from enrollment ] [ Designated as safety issue: No ]Measure of coronary plaques and a surrogate marker of ischemic heart disease.
- Agatston Score (CT) [ Time Frame: Will be assessed within 3 weeks from enrollment ] [ Designated as safety issue: No ]Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease
Whole blood Serum/plasma Urine
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Diabetes type 2
Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up)
Sex and age-matched healthy controls
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001532
|Contact: Kristian LF Jensen, MD||+45 firstname.lastname@example.org|
|Department of Medical Endocrinology, Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Kristian LF Jensen, MD +45 78462071 email@example.com|
|Principal Investigator:||Per L Poulsen, MD, Ph.D., dr.med.sci||Department of Medical Endocrinology, Aarhus University Hospital|