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Arterial Stiffness and Complication Risk in Type 2 Diabetes

NCT02001532 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2017-10-26

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Complications
  • Diabetic Angiopathies
  • Diabetic Nephropathies

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Per L Poulsen, MD, Ph.D., dr.med.sci · Department of Medical Endocrinology, Aarhus University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001532 on ClinicalTrials.gov