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

NCT ID: NCT03559842

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-04
• Study Completion Date: 2022-12-31

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.

Conditions

Morbid Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgery patients

Obese patients undergoing laparoscopic sleeve gastrectomy

No interventions assigned to this group

Non-surgery patients

Obese patients not undergoing laparoscopic sleeve gastrectomy (delayed or refused proposed treatment)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Maria Anastasia Ricci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Internal Medicine

Perugia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Graziana Lupattelli, Prof

Role: CONTACT

graziana.lupattelli@unipg.it

00390755784023

Facility Contacts

Graziana Lupattelli, Prof

Role: primary

graziana.lupattelli@unipg.it

00390755784023

Other Identifiers

2017-15

Identifier Type: -

Identifier Source: org_study_id