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OpenTrials
Completed

NCT Number: NCT02001532

Arterial Stiffness and Complication Risk in Type 2 Diabetes

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. White matter lesions (MRI)

    Time frame: 5 years

    A surrogate marker of the risk of stroke

  2. Albuminuria

    Time frame: 5 years

    A measure of kidney damage

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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