Diabetes Complications, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Diabetic Nephropathies
Conditions
Keywords
Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies, Myocardial Infarction, Stroke, Vascular Stiffness, Pulse Wave Analysis
Brief summary
Background 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. Hypothesis Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2. Aim 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: 1. in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and 2. 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. Methods 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.
Interventions
None listed
Sponsors
University of Aarhus
Aarhus University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age * Diabetes, type 2, diagnosed within 5 years from baseline (cases)
Exclusion criteria
* Non-diagnosed diabetes (healthy controls) * Acute or chronic infectious diseases * Kidney failure (requiring dialysis) * Pregnancy/breastfeeding * Prior or concomitant cancer disease * Contraindication for MRI (claustrophobia, magnetic implants or bodyweight above 120kg) * Contraindication for CT (estimated glomerular filtration rate \< 50 ml/min, Body Mass Index \> 35 kg/m2, heart arrhythmia, heart failure, aorta stenosis, contraindications for beta blockage or nitroglycerin or failure to cooperate)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White matter lesions (MRI) | 5 years | A surrogate marker of the risk of stroke |
| Albuminuria | 5 years | A measure of kidney damage |
| Segment Involvement Score (CT) | Will be assessed within 3 weeks from enrollment | Measure of coronary plaques and a surrogate marker of ischemic heart disease. |
| Agatston Score (CT) | Will be assessed within 3 weeks from enrollment | Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease |
Countries
Denmark
Outcome results
None listed