Clinical Trial: Arterial Stiffness and Complication Risk in Type 2 Diabetes

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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) a

Detailed Summary:
Sponsor: Aarhus University Hospital

Current Primary Outcome:

• White matter lesions (MRI) [ Time Frame: 5 years ]
  A surrogate marker of the risk of stroke
• Albuminuria [ Time Frame: 5 years ]
  A measure of kidney damage
• Segment Involvement Score (CT) [ Time Frame: Will be assessed within 3 weeks from enrollment ]
  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 ]
  Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Aarhus

Dates:
Date Received: November 21, 2013
Date Started: May 2014
Date Completion: July 2016
Last Updated: May 12, 2016
Last Verified: February 2016