NCT03559842

Sleeve-gastrectomy Efficacy in Morbid Obese Patient With a Focus on the Role of Inflammation

Status unknown Last updated 11 March 2020

What this trial tests

trial in Morbid Obesity in 400 participants. Status unknown.

Timeline

4 May 2017

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	University Of Perugia
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	400
Start date	4 May 2017
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Italy

Conditions studied

• Morbid Obesity — all drugs for Morbid Obesity →

Sponsor

University Of Perugia

Who can join

Adults 18 to 65, any sex, with Morbid Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Increased plasmatic NETs by-products in patients in severe obesity.
   D'Abbondanza M, Martorelli EE, Ricci MA, De Vuono S, et al · · 2019 · cited 51× · PMID 31604985 · DOI 10.1038/s41598-019-51220-x
2. Circulating Levels of Sclerostin Predict Glycemic Improvement after Sleeve Gastrectomy.
   Carbone F, Nulli Migliola E, Bonaventura A, Vecchié A, et al · · 2021 · cited 8× · PMID 33671861 · DOI 10.3390/nu13020623