Arterial Stiffness and Complication Risk in Type 2 Diabetes

October 25, 2017 updated by: Aarhus University Hospital

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Department of Medical Endocrinology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White matter lesions (MRI)
Time Frame: 5 years
A surrogate marker of the risk of stroke
5 years
Albuminuria
Time Frame: 5 years
A measure of kidney damage
5 years
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.
Will be assessed within 3 weeks from enrollment
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
Will be assessed within 3 weeks from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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