Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, diabetes complications, diabetic angiopathies, diabetic nephropathies
Sponsor Aarhus University Hospital
Collaborator University of Aarhus
Start date May 2014
End date May 2016
Trial size 140 participants
Trial identifier NCT02001532, 1-10-72-349-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients diagnosed with type 2 diabetes within 5 years from baseline (i.e. 10 years at follow-up)
Sex and age-matched healthy controls

Primary Outcomes

Measure
White matter lesions (MRI)
time frame: 5 years
Albuminuria
time frame: 5 years
Segment Involvement Score (CT)
time frame: Will be assessed within 3 weeks from enrollment
Agatston Score (CT)
time frame: Will be assessed within 3 weeks from enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Arterial Stiffness and Complication Risk in Type 2 Diabetes
Principal investigator Per L Poulsen, MD, Ph.D., dr.med.sci
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.