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.
Study Type
OBSERVATIONAL
Enrollment
400
Internal Medicine
Perugia, Italy
RECRUITINGflow-mediated dilation
ultrasound evaluation
Time frame: One year
obesity-related cardiomyopathy
cardiac ultrasonography
Time frame: One year
insulin resistance
HOMA index
Time frame: One year
ectopic adiposity
ultrasound evaluation of visceral fat
Time frame: One year
inflammation
high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10
Time frame: One year
blood pressure
systolic and diastolic blood pressure
Time frame: One year
carotid intima-media thickness
ultrasound evaluation
Time frame: One year
microcirculatory function
Laser-Doppler flowmetry
Time frame: One year
aortic stiffness
tonometry
Time frame: One year
cardiovascular assessment
anti-hypertensive therapy variation (number of drugs)
Time frame: One year
dyslipidemia
total cholesterol, triglycerides, HDL, LDL
Time frame: One year
liver function
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.
Time frame: One year
biliary acid and sterols assessment
laboratory analysis
Time frame: One year
bone metabolism assessment
vitamin D, PTH
Time frame: One year
nutritional assessment
sideremia, vitamin B12, folates
Time frame: One year
adipose tissue quantification
bioimpedentiometry
Time frame: One year
adipokines
chemerin, leptin and adiponectin plasmatic dosage
Time frame: One year
NETs
"Neutrophil extracellular traps" dosage
Time frame: One year
inflammatory bone remodeling markers
sclerostin, osteopontin, cathepsin K
Time frame: One year
macrophages commitment markers
interleukin-10
Time frame: One year
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