Relation of Visceral Fat and Associated Cytokines With Early Cardiovascular Complications in Type 1 Diabetes. (VISCERA)
Objective: To investigate whether visceral adipose tissue (VAT) and its adipokines contribute to early signs of cardiovascular disease, meaning coronary artery calcifications (CAC) and diastolic dysfunction in type 1 diabetes (T1DM).
Research Design & Methods: A cross-sectional study of T1DM patients without a history of cardiovascular disease. CAC and VAT are measured using a CT scan. CAC is scored using the Agatston method. Echocardiography is performed to assess contractile abnormalities. Serum levels of adipocytokines (adiponectin, leptin, IL-6 and TNF-a) are measured using ELISA assays.
Type 1 Diabetes
Coronary Artery Calcifications
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Relation of Visceral Fat and Associated Cytokines With Early Cardiovascular Complications in Type 1 Diabetes: the VISCERA Study|
- coronary artery calcifications [ Time Frame: once at the moment of inclusion of this cross-sectional, observational study ]A 64-slice non-contrast multidetector CT scan of the coronary arteries was performed to measure coronary artery calcifications (CAC) (Lightspeed, VCT; General Electric Medical Systems, Waukesha, Wis, Milwaukee, USA). Scoring was done by one skilled radiologist (R. Salgado), who was blinded to the subjects case files. Typical imaging parameters were: tube voltage 100 kv; current intensity 310 mA; rotation time 500 ms; and detector collimation 64 x 0.625 mm. Scan data were reconstructed at 75% of the cardiac cycle after the QRS complex. The radiation dose for calcium scoring ranged at 1.3-1.7 mSv. CAC was quantified (Agatston score) by means of a dedicated software application (SmartScore, AW). The Agatston score is the product of CAC area times the density.
- diastolic dysfunction [ Time Frame: once at the moment of inclusion of this cross-sectional, observational study ]Standard 2-dimensional and Doppler Echocardiography (iE-33 Philips, The Netherlands) was performed by a single cardiologist blinded to the clinical status of the study participants. Briefly, left ventricular function was assessed by the parasternal long axis M-mode and modified biplane Simpson method. Diastolic function was determined taking into account all the following parameters: mitral inflow, pulmonary vein inflow signal and mitral annular tissue Doppler (tD) velocities from end expiratory cycles
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
type 1 diabetic patients
Adult T1DM patients, aged 18-75 years, regularly attending the out-patient diabetes clinic of the Antwerp University Hospital are recruited starting from June 2011. Patients had to have a diabetes duration of ≥5 years and be in general good health to be included. Exclusion criteria were a history of a major adverse cardiovascular event (myocardial infarction, stroke), other cardiovascular complaints, pregnancy or a glomerular filtration rate ≤30 ml/min/1.73 m2.
no interventions; observational study
Other Name: no interventions; observational study
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02689570
|Contact: Christophe EM De Block, MD, PhDfirstname.lastname@example.org|
|Contact: Luc F Van Gaal, MD, PhDemail@example.com|
|Antwerp University Hospital||Recruiting|
|Edegem, Belgium, 2650|
|Contact: Christophe De Block, MD PhD +3238214364 firstname.lastname@example.org|
|Contact: Luc Van Gaal, MD PhD|
|Principal Investigator: Christophe De Block, MD PhD|
|Principal Investigator: Luc Van Gaal, MD PhD|
|Principal Investigator:||Luc F Van Gaal, MD, PhD||Universiteit Antwerpen|