Arterial Stiffness and Complication Risk in Type 2 Diabetes
1 other identifier
observational
140
1 country
1
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 26, 2017
February 1, 2016
2 years
November 21, 2013
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
White matter lesions (MRI)
A surrogate marker of the risk of stroke
5 years
Albuminuria
A measure of kidney damage
5 years
Segment Involvement Score (CT)
Measure of coronary plaques and a surrogate marker of ischemic heart disease.
Will be assessed within 3 weeks from enrollment
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
Study Arms (2)
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 Criteria
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.
You may qualify if:
- years of age
- Diabetes, type 2, diagnosed within 5 years from baseline (cases)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- University of Aarhuscollaborator
Study Sites (1)
Department of Medical Endocrinology, Aarhus University Hospital
Aarhus, 8000, Denmark
Related Publications (4)
Laugesen E, Rossen NB, Hoyem 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.
PMID: 23777282BACKGROUNDLaugesen E, Hoyem P, Stausbol-Gron B, Mikkelsen A, Thrysoe 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. Diabetes Care. 2013 Mar;36(3):722-8. doi: 10.2337/dc12-0942. Epub 2012 Nov 5.
PMID: 23129135RESULTLaugesen E, Hoyem 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. Cardiovasc Diabetol. 2013 Jul 18;12:107. doi: 10.1186/1475-2840-12-107.
PMID: 23866070RESULTFunck KL, Laugesen E, Ovrehus K, Jensen JM, Norgaard BL, Dey D, Hansen TK, Poulsen PL. Increased high-risk coronary plaque burden is associated with arterial stiffness in patients with type 2 diabetes without clinical signs of coronary artery disease: a computed tomography angiography study. J Hypertens. 2017 Jun;35(6):1235-1243. doi: 10.1097/HJH.0000000000001308.
PMID: 28441695DERIVED
Biospecimen
Whole blood Serum/plasma Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per L Poulsen, MD, Ph.D., dr.med.sci
Department of Medical Endocrinology, Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
December 5, 2013
Study Start
May 1, 2014
Primary Completion
May 1, 2016
Study Completion
July 1, 2016
Last Updated
October 26, 2017
Record last verified: 2016-02