Arterial Stiffness and Complication Risk in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Aarhus
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier:
NCT02001532
First received: November 21, 2013
Last updated: June 11, 2014
Last verified: November 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Arterial Stiffness and Complication Risk in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • White matter lesions (MRI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    A surrogate marker of the risk of stroke

  • Albuminuria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    A measure of kidney damage

  • Segment Involvement Score (CT) [ Time Frame: Will be assessed within 3 weeks from enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease


Biospecimen Description:

Whole blood Serum/plasma Urine


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001532

Contacts
Contact: Kristian LF Jensen, MD +45 78462071 klfj@ki.au.dk

Locations
Denmark
Department of Medical Endocrinology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Kristian LF Jensen, MD    +45 78462071    klfj@ki.au.dk   
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
Principal Investigator: Per L Poulsen, MD, Ph.D., dr.med.sci Department of Medical Endocrinology, Aarhus University Hospital
  More Information

Publications:
Responsible Party: University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier: NCT02001532     History of Changes
Other Study ID Numbers: 1-10-72-349-13
Study First Received: November 21, 2013
Last Updated: June 11, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Diabetes Mellitus, Type 2
Diabetes Complications
Diabetic Angiopathies
Diabetic Nephropathies
Myocardial Infarction
Stroke
Vascular Stiffness
Pulse Wave Analysis

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014