Arterial Stiffness and Complication Risk in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Arterial Stiffness and Complication Risk in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001532
• Other study ID #: 1-10-72-349-13
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: October 25, 2017
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Angiopathies
• Diabetic Nephropathies
• Kidney Diseases

Locations

Country	Name	City	State
Denmark	Department of Medical Endocrinology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Laugesen E, Høyem P, Christiansen JS, Knudsen ST, Hansen KW, Argraves WS, Hansen TK, Poulsen PL, Rasmussen LM. Plasma levels of the arterial wall protein fibulin-1 are associated with carotid-femoral pulse wave velocity: a cross-sectional study. Cardiovas — View Citation

Laugesen E, Høyem P, Stausbøl-Grøn B, Mikkelsen A, Thrysøe S, Erlandsen M, Christiansen JS, Knudsen ST, Hansen KW, Kim WY, Hansen TK, Poulsen PL. Carotid-femoral pulse wave velocity is associated with cerebral white matter lesions in type 2 diabetes. Diab — View Citation

Laugesen E, Rossen NB, Høyem P, Christiansen JS, Knudsen ST, Hansen KW, Hansen TK, Poulsen PL. Reproducibility of pulse wave analysis and pulse wave velocity in patients with type 2 diabetes. Scand J Clin Lab Invest. 2013 Aug;73(5):428-35. doi: 10.3109/00365513.2013.800578. Epub 2013 Jun 18. — View Citation

Outcome

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