Morbid Obesity
Conditions
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.
Interventions
None listed
Sponsors
University Of Perugia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.
Exclusion criteria
* renal or hepatic impairment * heart failure (New York Heart Association - NYHA II-IV) * secondary causes of obesity * major psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NETs | One year | Neutrophil extracellular traps dosage |
| adipose tissue quantification | One year | bioimpedentiometry |
| adipokines | One year | chemerin, leptin and adiponectin plasmatic dosage |
| aortic stiffness | One year | tonometry |
| flow-mediated dilation | One year | ultrasound evaluation |
| 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 |
| blood pressure | One year | systolic and diastolic blood pressure |
| carotid intima-media thickness | One year | ultrasound evaluation |
| microcirculatory function | One year | Laser-Doppler flowmetry |
| cardiovascular assessment | One year | anti-hypertensive therapy variation (number of drugs) |
| 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 |
| nutritional assessment | One year | sideremia, vitamin B12, folates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| macrophages commitment markers | One year | interleukin-10 |
| inflammatory bone remodeling markers | One year | sclerostin, osteopontin, cathepsin K |
Countries
Italy
Contacts
Primary ContactGraziana Lupattelli, Prof
Outcome results
None listed