Clinical trial NCT03559842: Sleeve-gastrectomy Efficacy in Morbid Obese Patient With a Focus on the Role of Inflammation
Official title: Sleeve-gastrectomy Efficacy in the Treatment of Metabolic and Vascular Dysfunction of Morbid Obese Patient With a Focus on the Role of Inflammation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Morbid obese patients with BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity)

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.


Eligibility criteria: 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

Primary outcomes:
measure: flow-mediated dilation
timeFrame: One year
measure: obesity-related cardiomyopathy
timeFrame: One year
measure: insulin resistance
timeFrame: One year
measure: ectopic adiposity
timeFrame: One year
measure: inflammation
timeFrame: One year
measure: blood pressure
timeFrame: One year
measure: carotid intima-media thickness
timeFrame: One year
measure: microcirculatory function
timeFrame: One year
measure: aortic stiffness
timeFrame: One year
measure: cardiovascular assessment
timeFrame: One year
measure: dyslipidemia
timeFrame: One year
measure: liver function
timeFrame: One year
measure: biliary acid and sterols assessment
timeFrame: One year
measure: bone metabolism assessment
timeFrame: One year
measure: nutritional assessment
timeFrame: One year
measure: adipose tissue quantification
timeFrame: One year
measure: adipokines
timeFrame: One year
measure: NETs
timeFrame: One year
Secondary outcomes:
measure: inflammatory bone remodeling markers
timeFrame: One year
measure: macrophages commitment markers
timeFrame: One year
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Internal Medicine
Study officials:
References: