Arterial Stiffness and Complication Risk in Type 2 Diabetes

Sponsor

Aarhus University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02001532

Collaborator

University of Aarhus (Other)

140

Enrollment

Location

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and
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 or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Diabetes Complications Diabetic Angiopathies Diabetic Nephropathies

Study Design

Study Type:

Observational

Actual Enrollment :

140 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Arterial Stiffness and Complication Risk in Type 2 Diabetes

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

White matter lesions (MRI) [5 years]
A surrogate marker of the risk of stroke
Albuminuria [5 years]
A measure of kidney damage
Segment Involvement Score (CT) [Will be assessed within 3 weeks from enrollment]
Measure of coronary plaques and a surrogate marker of ischemic heart disease.
Agatston Score (CT) [Will be assessed within 3 weeks from enrollment]
Measure of calcium in the coronary arteries and a surrogate marker of ischemic heart disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)