Arterial Stiffness and Complication Risk in Type 2 Diabetes

Aarhus University Hospital

Status: Completed

Conditions: Diabetic Nephropathies; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT02001532

1-10-72-349-13

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

140 participants in 2 patient groups

Diabetes type 2

Description:

Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up)

Healthy controls

Description:

Sex and age-matched healthy controls