Sleeve-gastrectomy Efficacy in the Treatment of Metabolic and Vascular Dysfunction of Morbid Obese Patient With a Focus on the Role of Inflammation
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- carotid intima-media thickness
研究概览
简要总结
Despite the wide range of studies concerning the positive effects of bariatric surgery on metabolic state of morbid obese patient, it is necessary to further investigate the specific role of the "sleeve-gastrectomy" intervention, going not only to research results in terms of safety or efficacy on the treatment of comorbidities, but also aimed to understand whether the improvement of metabolic and cardiovascular parameters is due to total weight loss or rather to visceral fat loss, and how much of this improvement is attributable to changes in inflammatory status. The primary endpoint of the study is to evaluate the effect of sleeve-gastrectomy on metabolic parameters (glyco-lipidic assessment, vitamins), bone-remodelling parameters (vitamin D, parathormone) and cardiovascular parameters (blood pressure, flow-mediated dilation, indexed left ventricular mass, inter-ventricular septum, carotid intima-media thickness) in a large obese population on the basis of total weight loss (TWL), variation of visceral fat area (VFA), variation of peri-renal fat thickness and insulin resistance index ("Homeostasis Model Assessment-insulin resistance" - HOMA). In addition the investigators set themselves the objective of assessing whether the presence of comorbidities (diabetes and hypertension) can influence the effects of the intervention on the above parameters, and whether the levels of the NETs and of adipokines such as chemerin in the pre- and post-intervention can correlate with the metabolic-vascular dysfunction, and play a role in its eventual improvement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.
排除标准
- •renal or hepatic impairment
- •heart failure (New York Heart Association - NYHA II-IV)
- •secondary causes of obesity
- •major psychiatric disorders
结局指标
主要结局
carotid intima-media thickness
时间窗: One year
ultrasound evaluation
microcirculatory function
时间窗: One year
Laser-Doppler flowmetry
aortic stiffness
时间窗: One year
tonometry
cardiovascular assessment
时间窗: One year
anti-hypertensive therapy variation (number of drugs)
adipokines
时间窗: One year
chemerin, leptin and adiponectin plasmatic dosage
obesity-related cardiomyopathy
时间窗: One year
cardiac ultrasonography
insulin resistance
时间窗: One year
HOMA index
ectopic adiposity
时间窗: One year
ultrasound evaluation of visceral fat
inflammation
时间窗: One year
high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10
dyslipidemia
时间窗: One year
total cholesterol, triglycerides, HDL, LDL
liver function
时间窗: One year
Evaluation of "Non-alcoholic fatty liver disease" (NAFLD) fibrosis score according to the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×109/l) - 0.66 × albumin (g/dl). Cutoffs: NAFLD Score \< -1.455 = low grade fibrosis; NAFLD Score -1.455 - 0.675 = indeterminate score; NAFLD Score \> 0.675 = high grade fibrosis.
biliary acid and sterols assessment
时间窗: One year
laboratory analysis
bone metabolism assessment
时间窗: One year
vitamin D, PTH
NETs
时间窗: One year
"Neutrophil extracellular traps" dosage
flow-mediated dilation
时间窗: One year
ultrasound evaluation
blood pressure
时间窗: One year
systolic and diastolic blood pressure
nutritional assessment
时间窗: One year
sideremia, vitamin B12, folates
adipose tissue quantification
时间窗: One year
bioimpedentiometry
次要结局
- macrophages commitment markers(One year)
- inflammatory bone remodeling markers(One year)
研究者
Maria Anastasia Ricci
Principal Investigator
University Of Perugia
