Sleeve-gastrectomy Efficacy in Morbid Obese Patient With a Focus on the Role of Inflammation
- Conditions
- Morbid Obesity
- Registration Number
- NCT03559842
- Lead Sponsor
- University Of Perugia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.
- renal or hepatic impairment
- heart failure (New York Heart Association - NYHA II-IV)
- secondary causes of obesity
- major psychiatric disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method microcirculatory function One year Laser-Doppler flowmetry
aortic stiffness One year tonometry
cardiovascular assessment One year anti-hypertensive therapy variation (number of drugs)
adipokines One year chemerin, leptin and adiponectin plasmatic dosage
obesity-related cardiomyopathy One year cardiac ultrasonography
insulin resistance One year HOMA index
ectopic adiposity One year ultrasound evaluation of visceral fat
inflammation One year high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10
dyslipidemia One year total cholesterol, triglycerides, HDL, LDL
liver function 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 One year laboratory analysis
bone metabolism assessment One year vitamin D, PTH
NETs One year "Neutrophil extracellular traps" dosage
flow-mediated dilation One year ultrasound evaluation
carotid intima-media thickness One year ultrasound evaluation
blood pressure One year systolic and diastolic blood pressure
nutritional assessment One year sideremia, vitamin B12, folates
adipose tissue quantification One year bioimpedentiometry
- Secondary Outcome Measures
Name Time Method inflammatory bone remodeling markers One year sclerostin, osteopontin, cathepsin K
macrophages commitment markers One year interleukin-10
Trial Locations
- Locations (1)
Internal Medicine
🇮🇹Perugia, Italy