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临床试验/NCT03559842
NCT03559842Unknown不适用

Sleeve-gastrectomy Efficacy in the Treatment of Metabolic and Vascular Dysfunction of Morbid Obese Patient With a Focus on the Role of Inflammation

University Of Perugia1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年5月4日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Anastasia Ricci

Principal Investigator

University Of Perugia

研究点 (1)

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