Relation of Visceral Fat and Associated Cytokines With Early Cardiovascular Complications in Type 1 Diabetes: the VISCERA Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- coronary artery calcifications
研究概览
简要总结
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.
详细描述
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).
Patients & Methods:
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 have to have a diabetes duration of ≥5 years and be in general good health to be included. Exclusion criteria are 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.
All participants sign an informed consent form. This study is conducted in accordance with the amended Declaration of Helsinki. The research protocol is approved by the Antwerp University Hospital Ethics committee (UZA 11/31/224, Belgian registration number: B30020111874).
Anthropometric measurements:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetic patients (criteria for diagnosis by the American Diabetes Association
- •diabetes duration ≥5 years
- •general good health
排除标准
- •having experienced a major adverse cardiovascular event (myocardial infarction,stroke)
- •having cardiovascular complaints
- •pregnancy
- •having an estimated glomerular filtration ≤ 30ml/min/1.73 m²
结局指标
主要结局
coronary artery calcifications
时间窗: 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.
次要结局
- diastolic dysfunction(once at the moment of inclusion of this cross-sectional, observational study)
研究者
Christophe De Block
MD PhD
University Hospital, Antwerp