Arterial Stiffness and Complication Risk in Type 2 Diabetes

Study Overview
=================
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: 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. 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.

Official Title
-----------------
Arterial Stiffness and Complication Risk in Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies

Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes type 2<br>Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up) | |
| Healthy controls<br>Sex and age-matched healthy controls | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White matter lesions (MRI) | A surrogate marker of the risk of stroke | 5 years | 
| Albuminuria | A measure of kidney damage | 5 years | 
| Segment Involvement Score (CT) | Measure of coronary plaques and a surrogate marker of ischemic heart disease. | Will be assessed within 3 weeks from enrollment | 
| Agatston Score (CT) | Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease | Will be assessed within 3 weeks from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Angiopathies, Diabetic Nephropathies, Myocardial Infarction, Stroke, Vascular Stiffness, Pulse Wave Analysis