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Arterial Stiffness and Complication Risk in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02001532
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

November 21, 2013
December 5, 2013
October 26, 2017
May 2014
May 2016   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT02001532 on ClinicalTrials.gov Archive Site
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Arterial Stiffness and Complication Risk in Type 2 Diabetes
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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Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Whole blood Serum/plasma Urine
Non-Probability Sample

100 patients with type 2 diabetes (cases) were enrolled from the outpatient clinic of the Department of Endocrinology, Aarhus University Hospital between 2008-11.

100 sex and age-matched healthy controls were recruited in the same time period through the local press.

  • Diabetes Mellitus, Type 2
  • Diabetes Complications
  • Diabetic Angiopathies
  • Diabetic Nephropathies
Not Provided
  • Diabetes type 2
    Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up)
  • Healthy controls
    Sex and age-matched healthy controls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
200
July 2016
May 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT02001532
1-10-72-349-13
No
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University of Aarhus ( Aarhus University Hospital )
Aarhus University Hospital
University of Aarhus
Principal Investigator: Per L Poulsen, MD, Ph.D., dr.med.sci Department of Medical Endocrinology, Aarhus University Hospital
University of Aarhus
February 2016